Endoscope sheath apparatuses

ABSTRACT

Sheaths that may be used with endoscopes, and in particular, robotic endoscopes and/or telescoping endoscopes, as well as method of using these sheaths to prevent cross-contamination between patients and contamination of the endoscope are described. These sheaths include both an outer sheath for covering the outside of the endoscope and one or more inner sheaths for covering a lumen of the endoscope, and are configured so as not to interfere with the flexibility or operation of the endoscope. These sheaths may reduce or eliminate the need for endoscope cleaning.

CLAIM OF PRIORITY

This patent application claims priority as a continuation of PCTApplication No. PCT/US2023/066293, titled “HYGIENIC SHEATH FORENDOSCOPY,” filed on Apr. 27, 2023, which claims priority to U.S.Provisional Patent Application No. 63/335,720, titled “HYGIENIC DRAPINGFOR ROBOTIC ENDOSCOPY,” filed on Apr. 27, 2022. These applications areherein incorporated by reference in their entireties.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference in their entirety to the sameextent as if each individual publication or patent application wasspecifically and individually indicated to be incorporated by reference.

BACKGROUND

Reusable endoscopes (‘scopes’), both manually and robotically operated,perform important diagnostic and therapeutic functions, but havenumerous issues. Endoscopes may be difficult to clean because they maybe a long length (an enteroscope may be over two meters long), may haveone or more very long and very small lumens, and they include amultitude of small, ornate parts constructed from a wide variety ofmaterials that have regions that may shelter microbes. These regions mayinclude regions where parts meet, in cracks and connections, and regionswhere there are scratches and localized damage. The use of mostendoscopes typically requires them to be immersed in pathogen-richcontaminants, including blood, feces, urine, and diseased and infectedtissue. Reusable scopes are expected to survive a very large number ofcases—often over one thousand—over a long period of time, e.g., severalyears. However, such long-life expectations create issues: a carefulanalysis of used scopes shows them to be often damaged both internallyand externally. The repair of endoscopes is logistically taxing,requires constant quality-control and inspection, requires expensiveback-up devices, shipping, receiving and proper packaging and transport,and is very expensive: a reusable scope typically has lifetime repaircosts that exceed the cost of the initial purchase. Because reusablescopes are expected to last for years, it inherently means thatclinicians are performing endoscopy with outdated technology. Cleaningscopes also requires considerable capital equipment, as well as theirrequisite space, training, maintenance, and repair. Successful cleaningof scopes requires the successful execution of highly detailedprocedures (often over one hundred separate steps) and often by staffthat has significant turnover, is ill-trained, is hurried, is in poorcommunication with the end-user, and is working without all of thenecessary tools. It is well-documented that scope cleaning is notusually performed accurately and completely, as per the full andcomplete list of cleaning instructions. The complete set of activitiesnecessary to clean and return scopes ready for their next case requiresa complicated, time-consuming, multi-person, expensive internallogistics dance as the devices move throughout their various steps invarious locations within the hospital, with different tasks beinghanded-off between a large number of different people and departments.Hospital space is very expensive, and the storage, processing, andmovement of these devices creates very real facility costs. Furthermore,the cleaning process often takes the devices out of commission forextended periods of times, requiring that facilities that performendoscopy maintain a vast arsenal of rotating devices to fulfill theirongoing procedures. Further, despite the impression that re-use is goodfor the environment, the cleaning of scopes creates a remarkably largeamount of landfill—gloves, wipes, brushes, personal protective gear,connectors, tubing, test strips, and hazardous chemicals. The chemicalcleaning agents are harsh for the scope, the facility, the environment,and the people performing the cleaning.

Importantly, such cleaning processes may clean a scope, but theprocessed scope is not sterile (the goal is HLD, High LevelDisinfection), because many of the scope's materials cannot withstandthe rigors of the requisite chemicals, temperatures, or radiation.Sterilization via ethylene oxide would require long exposure andaeration times, is hazardous to personnel and patients, and has createda large number of very public recent adverse worker health andenvironmental issues. Sterilization via peroxide is new and promising,but it would still suffer from the majority of above-listed maladies. Inthe worst case, peroxide-sterilized devices would be sterile, but wouldstill maintain debris burden which could be transferred fromcase-to-case. Scope contamination is pervasive and, in the worst cases,has resulted in disease transmission and documented deaths.

Currently available resposable scopes are expected to last for multiplecases (e.g., 2, 5, 10, 20, etc.) and suffer from many of the same issuesas reusable scopes.

Although disposable scopes typically arrive sterile and never need to becleaned, they result in significant landfill waste and may be difficultto manufacture at high quality and reasonable costs. Though they couldtheoretically be recycled, actual recycling is painfully rare and isuneconomical. Disposable scopes have found effective use in certainniches, but they have not been widely adopted.

Surgical drapes, sheaths, and shrouds are used to create a sterile fieldaround a surgical site and establish a physical barrier that reduces therisk of device contamination and surgical site infections. Sheathing canbe a key enabler to freeing technicians required to clean waste (e.g.,feces) from endoscopes to pursue more meaningful and important work.Hygienic draping, including for both manual and robotic/teleroboticendoscopy, may effectively physically isolate the device from thepatient during surgical procedures.

Thus, there is a need for methods, components, systems, and apparatusesto addresses these issues.

SUMMARY OF THE DISCLOSURE

Described herein are methods and apparatuses (e.g., components,accessories, devices and systems, including sheath systems) that may beused with endoscopes, and in particular, manual endoscopes or roboticendoscopes and/or telescoping endoscopes, as well as method of usingthese sheaths to prevent cross-contamination between patients andcontamination of the endoscope. In general, these sheaths may reduce oreliminate the need for endoscope cleaning. The sheaths described hereinmay also or alternatively be referred to as drapes and mayadvantageously be quickly and easily applied to an endoscope system fora new patient without a lengthy reprocessing procedure that wouldotherwise include HLD and/or sterilization. These sheaths may protectthe outside of the endoscope as well as any internal working channelsand supply lines of the endoscope, which may critically preventcontamination of endoscopes with internal working channels and supplylines during medical procedures. The apparatuses (e.g., components,accessories, devices and systems, including sheath devices and sheathsystems) and methods described herein may protect patients fromcross-contamination including cross-contamination from other patients,may be faster, easier, and lower cost, may result in less landfill, andmay be more effective than reprocessing (cleaning of the endoscope). Byreducing or eliminating additional cleaning cycles, the endoscopes mayhave less wear and associated damage. By effectively sheathing thedevices, important scope elements can be reused multiple times, therebyreducing per-case cost and reducing landfill.

The method and apparatuses (e.g., systems and devices, including sheathsystems) described herein may include reusable elements, disposableelements, semi-disposable elements (i.e., resposable elements, elementsthat are reused a modest number of times), and/or draping elements thatmay address the issues raised above.

As used herein the term “endoscope” is intended to be understoodbroadly. In general, an endoscope may refer to an instrument which canbe introduced into the body and may include one or more lumens extendingtherethrough. An endoscope may include a catheter, trocar, tube, or thelike. An endoscope may refer to an instrument for use in examining,accessing, treating and/or diagnosing the interior of a body, includingan organ, lumen, body cavity or vessel. Any of these endoscopes mayinclude imaging (e.g., typically by a CCD, CMOS chip, or fiber opticmaterial) to give a view from the distal end or sides of the device. Theendoscopes described herein may include sensing (e.g., electricalsensing, magnetic sensing, shape sensing, mechanical sensing, etc.). Theendoscope may generally be a catheter including one (or more than one)internal lumen extending the length of the endoscope. In some examplesthe endoscope may include one or more internal lumens extending thelength of the endoscope (e.g., an internal working channel, fluidchannels, insufflation channels, wash channels, etc.). For example, anyof these endoscopes may include a channel or channels for applying orremoving liquid and/or gas (e.g., aspiration/suction, spray, wash,insufflation). These channels may be co-joined with electrical elements,including wiring for lighting, vision, the delivery of energy, orsensing. These endoscopes may include a channel or channel for tools orinstruments. This channel may be multi-use, including for aspiration orwash. Any of the endoscopes described herein may include an internallumen configured as an internal working channel, e.g., for passing oneor more accessory devices. Examples of endoscopes may include, but arenot limited to colonoscopes, arthroscopes, bronchoscopes, cystoscopes,enteroscopes, esophagogastroduodenoscopes, hysteroscopes, laparoscopes,laryngoscopes, mediastinoscopes, sigmoidoscopes, or thoracoscopes, etc.

The methods and apparatuses described herein may be particularly wellsuited for manual endoscopes. A manual endoscope may be manually steeredusing a control (e.g., knob, button, lever, dial, etc.) to steer thedistal tip region, and may be advanced or retracted manually. Thesheaths described herein may be configured to work on or with a manualendoscope, so that the distal cap may fit over the distal end of themanual endoscope, the external sheath (sealed to the cap) may fit overthe outer surface of the endoscope and the one or more internal sheaths(also sealed to the cap) may fit through and line any inner lumen of theendoscope.

The methods and apparatuses described herein may be particularly wellsuited for use with telescoping system, in which an inner endoscope isconcentrically arranged with an outer tube. The inner endoscope and theother endoscope may be moved together (e.g., to advance) and/orseparately. All operations of the inner endoscope (also referred toherein as the “child”) may be protected by the sheaths described hereinand may therefore be reusable a certain number of times, orsemi-disposable or resposable (meaning that it is reused a certainnumber of times, for example 2 to 40 times). In some examples, the outerendoscope tube (which may also be referred to herein equivalently as a“mother,” an outer member or as an overtube) may be reusable or may bedisposable. The mother may be reusable the same number of times as thechild, or it may be reusable a different number of times than the child,or one of the elements may be single use. For example, the outer tubemay be completely or partially covered by the external sheath. Invariations in which the outer tube is extensively covered by theexternal sheath (e.g., completely or mostly covered, or covered withinthe sterile field) the outer tube may be reused after removing thesheath following a procedure. In variations in which the external sheathis connected only distally (e.g., sealed to the distal end or distal endregion of the outer tube) the outer tube may be single-use or mayrequire cleaning and/or sterilizing before reuse. Since the outer tubemay be easier, faster, and/or cheaper to clean than the endoscope thismay still be a net savings. The outer tube may also be an endoscope.

As mentioned, the endoscope may equivalently include (and/or be replacedwith) a catheter. In examples including an inner endoscope and an outertube, the majority of the length of the inner member (equivalentlyreferred to herein as an endoscope, inner endoscope, or “child”) may besheathed by the outer tube, which may be of special construction suchthat it is referred to as a ‘ruggedized’ sheath; the distal portionincluding the external sheath may be a thin film sheath. This can haveclinical benefits, e.g., when the endoscope is configured for insertioninto the rectum, as the portion that is sliding through the anus for themajority of the procedure may be ruggedized, and sheath wear isminimized, so reliability is increased.

In general, the apparatuses and methods described herein may be usedwith one or more rigidizing members. In examples including an endoscope,the endoscope may be a rigidizing member, e.g., a selectively rigidizingmember. In examples including an endoscope and an outer tube both theinner endoscope and outer tube may be rigidizing members, or just theouter or just the endoscopes may be rigidizing.

For example, described herein are endoscope sheath apparatuses (e.g.,systems, devices, etc.) comprising: an external sheath; a cap sealinglycoupled to a distal end of the external sheath; and an internal sheathhaving one or more lumens and extending within the external sheath,wherein the internal sheath is sealingly coupled to the cap so that theone or more lumens are open through the cap.

For example, an endoscope sheath device configured to preventcontamination of an endoscope may include: an external sheath; a capsealingly coupled to a distal end of the external sheath; and one ormore internal sheaths each extending within the external sheath, whereineach internal sheath has one or more internal lumens, further whereineach internal sheath is sealingly coupled to the cap so that the one ormore internal lumens is open through the cap.

In some examples an endoscope sheath device configured to preventcontamination of an endoscope may include: a flexible external sheathconfigured to extend over the endoscope to form an impermeable externalbarrier; a cap sealingly coupled to a distal end of the external sheath,wherein the cap is configured to mate with a distal end of theendoscope; and one or more internal sheaths each having one or moreinternal lumens, each of the one or more internal sheaths extendingwithin the flexible external sheath, wherein each of the one or moreinternal sheaths are configured to pass through a lumen of the endoscopeto form an impermeable internal barrier, wherein each of the one or moreinternal sheaths is sealingly coupled to the cap so that the one or moreinternal lumens are open through the cap.

Thus, in general the sheath devices (including the cap, outer andinternal sheath devices) described herein may form an impermeablecontamination barrier. The impermeable contamination barrier may beimpermeable to fluid and/or solids. The barrier may be sterile orsterilized. Optionally the barrier does not have to be sterile, but maybe clean and may prevent contamination of the endoscope to which it isattached. The endoscope does not need to be sterile or remain sterile,but may be kept clean and free of contaminants by the sheath devicesdescribed herein. In particular both external and internal (e.g.,channels, lumen, etc.) of the endoscope may be kept clean and free ofcontaminant as the sheath devices described herein may effectivelygenerate a barrier to prevent contamination. Importantly, these sheathdevices are configured to be removed without contamination of theendoscope covered by the sheath, either externally or internally.

An endoscope sheath device configured to prevent contamination of anendoscope may include: a flexible external sheath configured to fit overthe endoscope; a cap sealingly coupled to a distal end of the externalsheath; one or more internal sheaths each extending within the externalsheath and configured to fit within a lumen extending through theendoscope, wherein each internal sheath has one or more internal lumens,further wherein each internal sheath is sealingly coupled to the cap sothat the one or more internal lumens is open through the cap; and asealing region at a proximal end of each of the one or more internalsheaths that is configured to be sealed after use to preventcontamination during removal of the one or more internal sheaths fromwithin the lumen extending through the endoscope.

For example, in some examples, the external sheath comprises a flexible,thin, resilient material. The external sheath may be comprised of one ormore materials, including plastics, elastomers, plastomers, or compositematerials. Plastomers include polymer materials which combine qualitiesof elastomers and plastics, such as rubber-like properties with theprocessing ability of plastic. Plastomers may include ethylene-alphaolefin copolymers. Appropriate materials may include latex,polyvinylchloride, polyurethane, polyethylene, polypropylene, silicone,or other similar materials. The material may be reinforced throughlamination, including with fibers or metals. In some examples the distalend (e.g., distal 10% or more, distal 15% or more, distal 20% or more,distal 25% or more, distal 30% or more, distal 35% or more, etc.) of theexternal sheath may be a thin-walled sheath, while the rest of theexternal sheath may be ruggedized. A ruggedized sheath may be thicker(e.g. having a wall thickness of 0.1 mm or greater, 0.2 mm or greater,0.25 mm or greater, 0.3 mm or greater, 0.35 mm or greater, 0.4 mm orgreater, 0.5 mm or greater, 0.55 mm or greater, 0.6 mm or greater, 0.7mm or greater, 0.8 mm or greater, 0.9 mm or greater, 1 mm or greater,etc.). Depending on the material forming the sheath, a thin-walledsheath may have a thickness of, e.g., 0.2 mm or thinner, 0.15 mm orthinner, 0.1 mm or thinner, 0.05 mm or thinner, 0.04 mm or thinner, 0.02mm or thinner, between about 0.25 mm to 0.01 mm thick, between about 0.2mm to 0.02 mm thick, etc.). The sheath may be formed of a singlematerial having different regions (e.g., thin-walled region andthicker-walled or ruggedized region) or a sheath may be formed ofdifferent materials that are coupled (e.g., fused, sealed, etc.)together.

In general, the external sheath may be shorter than the internal sheath.For example, the external sheath may extend just to the tip of anelongate outer tube (e.g., an elongate outer tube); in some examples theexternal sheath may extend along the length of the elongate outer tube.

The cap may be polymeric material that may be transparent and/or mayinclude a transparent window configured to align with a camera of anendoscope to allow imaging therethrough. The cap may be configured tocouple to a distal end of an endoscope. In some examples the cap isconfigured to secure to a distal end of an endoscope. For example, thereare multiple methods that could be used to attach the cap. Examples mayinclude one or more of: a shear surface configured to secure the cap tothe distal end of the endoscope, a snap fit configured to secure the capto the distal end of the endoscope, a magnet configured to secure thecap to the distal end of the endoscope, a bayonet connector configuredto secure the cap to the distal end of the endoscope, or a threadedregion configured to secure the cap to the distal end of the endoscope.

In any of the apparatuses described herein the external sheath may havea lower buckling resistance than the internal sheath(s). Thus, theinternal sheath(s) may have a higher axial compression stiffness thanthe external sheath; the external sheath may be configured to buckle(e.g., to scrunch, pleat, gather, stack up on itself, etc.) whereas theinternal sheath(s) are configured to resist buckling. In some examplesthe internal sheath comprises a multi-lumen catheter. For example, theinternal sheath may be formed as an elongate, flexible single-lumen ormulti-lumen catheter. The internal sheath may be formed of a polymericmaterial such as polyvinylchloride, polyurethane, polyethylene,polypropylene, etc. The internal sheath(s) may be a composite structure,including wire or fiber reinforced. The internal sheath(s) may haveelements to facilitate sliding (either along its inside surface or alongits outer surface), during install, during use (including allowing toolsto pass), and during un-install/removal. The constituents of theinternal sheath may vary along its length, including material and/ordurometer. In general, the internal sheath may also be referred to as aninternal sheath and may be longer than the endoscope into which it is tobe inserted so that the internal sheath extends proximally from theendoscope where it may engage with a port adapter (also referred toequivalently herein as a port adapter manifold) to provide access intoor out of the lumen (or lumens) of the internal sheath.

For example, when the internal sheath has multiple lumens (e.g., isconfigured as a multi-lumen catheter), the proximal end of the internalsheath may include one or more openings into an internal lumen of theone or more lumens at a proximal end region of the internal sheath. Forexample, this could be end openings and/or side openings. In someexamples, the internal sheath includes a plurality of radiallyspaced-apart (and optionally laterally or axially spaced-apart) sideopenings at a proximal end region of the internal sheath, wherein eachradially spaced-apart side openings open into a lumen of the multi-lumencatheter. The port adapter may couple to the end of the inner lumen(e.g., the multi-lumen catheter) to align the opening(s) of the internalsheath with ports or directly with a source of suction, pressurized air(‘insufflation’), a source fluid (e.g., saline), etc. In general, a portadapter may be configured to couple with the multi-lumen catheter tocreate isolated ports in fluid connection with each lumen of themulti-lumen catheter. The internal sheath, therefore, despite being adisposable component that may be thin and small and with multiplelumens, can be quickly, easily, and accurately attached, retained, (andsubsequently detached) to a structure such as a port adapter that canreadily plumb to a multitude of inputs. This adaption with the portadapter can work with single lumen internal sheaths, and with multiplelumen internal sheaths.

Any of these apparatuses may include multiple internal sheaths. In someexamples, the apparatus includes a second internal sheath configured asa working channel liner. The working channel liner may have a workingchannel lumen and extend within the external sheath adjacent to theinternal sheath, wherein the working channel liner is sealingly coupledto the cap so that the working channel lumen is open through the cap. Aworking channel may include a single lumen and may permit one or moretools to enter proximally and then exit distally. The working channelmay be used for suction or for irrigation.

Both the external sheath and the one or more internal sheaths may besealingly attached to the cap to prevent a barrier to fluid and/ormicroorganisms preventing access to the endoscope. In some examples theexternal sheath and/or the internal sheath (including a working channellumen) may be coupled to the cap with a weld, an ultrasonic weld, and/oran adhesive to form the sealing attachment.

Any of these apparatuses may include a proximal attachment on theexternal sheath configured to secure the external sheath to an outersurface of an endoscope. The proximal attachment may be an elasticmaterial that may elastically attach or secure the external sheath tothe outer surface of the endoscope. In some examples the proximalattachment may comprise a sealing attachment (e.g., a gasket, such asbut not limited to an O-ring; an adhesive material; etc.). In general,the proximal attachment for the external sheath may hold the externalsheath over the endoscope and/or against the endoscope (in examples inwhich the sheath is used with a single endoscope by itself) or againstan elongate outer tube (in examples in which the sheath is used with atelescoping assembly including an elongate outer tube and an innerendoscope that are coaxially arranged).

After the internal sheath has been used, it must be withdrawn so that itcan be disposed of, such that the endoscope is ready for a fresh and newsheath system. Given that contaminated fluids have passed through theinternal sheath, the internal sheath should be cleanly and effectivelyterminated, so that it does not present a contamination risk. To do so,the internal sheath can be crimped, including with a metal tube that isradially compressed. It could be sealed with an adhesive that cures (forexample, with UV curing). It could be heat sealed, such that the lumenis effectively sealed and terminated. The diameter of the sealed unitmust be no larger than that of the lumen through which it will bepulled, or otherwise it would not be removeable. In any of theseexamples, once the one or more internal sheaths are sealed, it/they maybe cut while still remaining contaminant-free—with a short portionstaying behind in the port adapter, and the long portion subsequentlysliding out distally. These methods may seal off the internal sheath toprevent contamination when removing the endoscope sheath device from anendoscope.

For example, described herein are endoscope sheath devices comprising: aflexible external sheath; a cap sealingly coupled to a distal end of theflexible external sheath, wherein the cap is configured to be sealed toa distal end of an endoscope; an internal sheath having one or morelumens and extending within the flexible external sheath, wherein theinternal sheath is sealingly coupled to the cap so that the one or morelumens are open through the cap; and a working channel liner (e.g., asecond internal sheath) having a working channel lumen and extendingwithin the flexible external sheath adjacent to the internal sheath,wherein the working channel liner is sealingly coupled to the cap sothat the working channel lumen is open through the cap.

Any of the apparatuses described herein may be configured as a sheathassembly including the sheath components described above, e.g., externalsheath, internal sheath(s) and cap integrated with an outer tube of atelescoping arrangement (e.g., an outer catheter, overtube, or otherouter elongate member having an inner lumen into which the endoscope maybe positioned). For example the external sheath may be fused orotherwise connected (including sealingly connected) to the outer surfaceof the elongate outer tube to form the sheath assembly. Multiple suchsheath assemblies may be used with the same endoscope so that it may beattached and removed without dirtying or compromising the cleanliness ofthe endoscope, as described herein.

For example, described herein are systems comprising a flexible outertube for use with an inner endoscope in a telescoping arrangement, thesystem comprising: an elongate outer tube, the elongate outer tubecomprising an outer tube lumen; an external sheath coupled to a proximalend region of the elongate outer tube at a first end region; a capsealingly coupled to a second end of the external sheath; and aninternal sheath having one or more internal sheath lumen and extendingwithin the external sheath and within the outer tube lumen, wherein theinternal sheath is sealingly coupled to the cap so that the one or moreinternal sheath lumen are open through the cap.

These systems may include any of the features described above. Further,the cap may be configured to couple to a distal end of the innerendoscope and the internal sheath may be configured to extend through alumen of the inner endoscope. As mentioned, in general the sheathapparatuses described herein may be used with non-rigidizing members, aswell as rigidizing members (e.g., rigidizing endoscopes, catheters,and/or overtubes). For example, the elongate outer tube may beconfigured to be selectively rigidized. The elongate outer tube may beconfigured to be selectively rigidized by multiple techniques, includingthe application of positive pressure or negative pressure. Devices maybe robotically operated, or they may be manually operated.

Also described herein are methods of using any of these apparatuses,which may include methods of applying and/or removing the sheaths fromthe endoscope or assemblies (e.g., telescoping assemblies) includingendoscopes, and methods of keeping an endoscope clean using the sheathapparatus. For example, a method of attaching a sanitary sheath to anendoscope may include: inserting an internal sheath through a lumen ofthe endoscope from a distal end to a proximal end so that one or moreinternal sheath lumen extend through the endoscope from the distal endto the proximal end; positioning an external sheath over the endoscopeso that the external sheath extends proximally from the distal end; andsecuring a cap to the distal end of the endoscope, wherein the externalsheath is sealingly connected to the cap and the internal sheath issealingly connected to the cap so that the internal sheath lumen areopen through the cap.

Positioning the external sheath over the endoscope may includepositioning the endoscope within an elongate outer tube so that theendoscope may move telescopically relative to the elongate outer tube.Inserting the internal sheath through the lumen of the endoscope maycomprise inserting a multi-lumen catheter forming the internal sheaththrough the lumen of the endoscope.

Once positioned, in some examples these methods may include coupling theinternal sheath to a port adapter at a proximal end region of theinternal sheath. Any of these methods may include coupling each of thelumen of the multi-lumen catheter to a port adapter at a proximal endregion of the internal sheath to provide isolated access to each lumen.

The proximal end of the flexible outer tube may be connected, includingto the base of an endoscope (for a manual procedure) or to matinggeometry on a capital base (for a robotic procedure). Once the procedureis completed, this feature may then be disconnected or disengaged.

In some examples attaching the cap to the distal end of the endoscopecomprises securing the cap to the distal end of the endoscope using oneor more of: a snap fit, a friction fit, a magnet coupler, a bayonetconnector or a threaded region.

For example, a method of maintaining cleanliness of an endoscope mayinclude: performing a medical procedure with an endoscope, such that adistal end of the endoscope is covered by a cap, wherein an internalsheath that is sealingly connected to the cap extends through a lumen ofthe endoscope from a distal end to a proximal end so that one or moreinternal sheath lumen extends through the lumen of the endoscope and areopen through the cap, further wherein an external sheath is sealinglyconnected to the cap and extends proximally over the endoscope andconnects to lumens at the proximal end; removing the cap from the distalend of the endoscope; and withdrawing the endoscope proximally out ofthe external sheath so that the internal sheath is extended out of thedistal end of the lumen of the endoscope, wherein a proximal end regionof the internal sheath has been sealed closed.

Performing the medical procedure may comprise passing material into orout of the one or more internal sheath lumen through the cap and/orimaging through the cap (e.g., through an imaging window and/or througha transparent cap or region of the cap). The external sheath may becoupled to an outer surface of an outer tube and the endoscope istelescopically arranged within the outer tube. Performing the medicalprocedure may comprise moving the endoscope proximally or distallyrelative to the outer tube. In any of these apparatuses, withdrawing theendoscope proximally out of the external sheath may comprise withdrawingthe endoscope proximally from the outer tube.

Any of these methods may include sealing the proximal end region of theinternal sheath. For example, sealing the proximal end region maycomprise crimping the proximal end region. Sealing the proximal endregion may comprise heat-sealing the proximal end region.

Any of the apparatuses (e.g., devices) described herein may include aninternal sheath that is a multi-lumen extrusion (e.g., a multi-lumencatheter) having 2 or more sub-lumen (e.g., 3 lumen, 4 lumen, etc.). Aninternal sheath comprising a multi-lumen catheter may be used to converta single lumen of an endoscope into multiple separate lumen.Apparatuses, e.g., devices, including multi-lumen internal sheaths maybe used to deliver a variety of different things, such as suction,insufflation, rinse solution, etc. These apparatuses may be adapted foruse with a port adapter that may provide reliable access to thedifferent lumen of the multi-lumen internal sheath. For example, anendoscope sheath device configured to prevent contamination of anendoscope may include: an external sheath; a cap sealingly coupled to adistal end of the external sheath; and an internal sheath comprising amulti-lumen catheter extending within the external sheath, wherein theinternal sheath is sealingly coupled to the cap so that the lumen of themulti-lumen catheter are open through the cap; and a plurality ofradially spaced-apart side openings at a proximal end region of theinternal sheath, wherein each side opening opens into an internal lumenof the multi-lumen catheter. The proximal end region of the internalsheath may be configured to mate with a port adapter to create isolatedports in fluid connection with each lumen of the multi-lumen catheter.

For example, a method of attaching a sanitary sheath to an endoscope mayinclude: inserting an internal sheath through a lumen of the endoscopefrom a distal end to a proximal end so that one or more internal sheathlumen extends through the endoscope from the distal end to the proximalend; positioning an external sheath over the endoscope so that theexternal sheath extends proximally from the distal end; and attaching acap to the distal end of the endoscope, wherein the external sheath issealingly connected to the cap and the internal sheath is sealinglyconnected to the cap so that the internal sheath lumen is open throughthe cap.

The internal sheath comprises a multi-lumen catheter and whereininserting the internal sheath through the lumen of the endoscopecomprises inserting the multi-lumen catheter through the lumen of theendoscope. The internal sheath may include a working channel liner andwherein inserting the internal sheath through the lumen of the endoscopecomprises inserting the working channel liner through the lumen of theendoscope. Any of these methods may include inserting a second internalsheath through a second lumen of the endoscope from the distal end tothe proximal end so that an internal sheath lumen of the second internalsheath extends through the endoscope from the distal end to the proximalend. The internal sheath may include a multi-lumen catheter and furthercomprising coupling the internal sheath to a port adapter at a distalend region of the internal sheath to create isolated ports in fluidconnection with each lumen of the multi-lumen catheter.

Attaching the cap to the distal end of the endoscope may includesecuring the cap to the distal end of the endoscope using one or moreof: a snap fit, a friction fit, a magnet coupler, a bayonet connector ora threaded region. Attaching the cap to the distal end of the endoscopemay comprise manually compressing (e.g., using two or more fingers tocompress) a cylindrical mating surface of the cap that is configured tomate with a distal end of the endoscope from an oval restingcross-sectional configuration into a circular mating cross-sectionalconfiguration.

Positioning the external sheath over the endoscope may includepositioning the endoscope within an elongate outer tube so that theendoscope may move telescopically relative to the elongate outer tube.

For example, a method of maintaining cleanliness of an endoscope mayinclude: performing a medical procedure with an endoscope while a distalend of the endoscope is covered by a cap, wherein an internal sheaththat is sealingly connected to the cap extends through a lumen of theendoscope from a distal end to a proximal end and so that one or moreinternal sheath lumen extends through the lumen of the endoscope and areopen through the cap, further wherein an external sheath is sealinglyconnected to the cap and extends proximally over the endoscope; removingthe cap from the distal end of the endoscope; and withdrawing theendoscope proximally out of the external sheath so that the internalsheath is extended out of the distal end of the lumen of the endoscope,wherein a proximal end region of the internal sheath has been sealedclosed. Performing the medical procedure may include passing materialinto or out of the one or more internal sheath lumen through the cap.Performing the medical procedure may include imaging through the cap(e.g., a lens on the cap). The external sheath may be coupled to anouter surface of an outer tube and the endoscope is telescopicallyarranged within the outer tube.

Performing the medical procedure may comprise moving the endoscopeproximally or distally relative to the outer tube. Withdrawing theendoscope proximally out of the external sheath may include withdrawingthe endoscope proximally from the outer tube. As mentioned, any of thesemethods may include sealing the proximal end region of the internalsheath. For example, sealing the proximal end region may comprisecrimping the proximal end region. In some examples sealing the proximalend region comprises heat-sealing the proximal end region.

As mentioned above, any of these apparatuses (e.g., sheaths) may beconfigured to include a crimping region at a proximal end region of theinternal sheath that is configured to be crimped to seal the one or morelumens after use to prevent contamination during removal of the internalsheath from within a lumen of the endoscope. The crimping region mayinclude a region that is formed of material (e.g., a metallic material,such as a cuff or link region) that is able to hold a crimp withoutleaking. In some examples the crimping region may be configured to melt.For example, the crimping region may be configured to be heat sealedand/or pressure sealed. The crimping region may be formed of orsupplemented with a different material than the reasons proximal and/ordistal to the crimping region. As used herein crimping may include bothmechanical crimping (e.g., pinching off of the lumen) as well as thermalcrimping (e.g., heating/melting the lumen so that it closes), or somecombination of these. Crimping may deform the material forming the lumenand/or an additional material on or around the lumen.

For example, an endoscope sheath device configured to preventcontamination of an endoscope may include: a flexible external sheath; acap sealingly coupled to a distal end of the external sheath; and aninternal sheath comprising a multi-lumen catheter extending within theexternal sheath, wherein the internal sheath is sealingly coupled to thecap so that the lumen of the multi-lumen catheter are open through thecap, further wherein the internal sheath is less flexible than theexternal sheath and is configured to extend through a lumen of theendoscope; and a plurality of radially and/or axially spaced-apart sideopenings at a proximal end region of the internal sheath, wherein eachside opening opens into an internal lumen of the multi-lumen catheter,further wherein the proximal end region of the internal sheath isconfigured to mate with a port adapter to create isolated ports in fluidconnection with each lumen of the multi-lumen catheter.

An endoscope sheath device configured to prevent contamination of anendoscope may include: a flexible external sheath configured to extendover the endoscope; a cap sealingly coupled to a distal end of theexternal sheath; and an internal sheath comprising a multi-lumencatheter extending within the external sheath, wherein the internalsheath is sealingly coupled to the cap so that the lumen of themulti-lumen catheter are open through the cap, further wherein theinternal sheath is configured to extend through a lumen of theendoscope; a plurality of radially and/or axially spaced-apart sideopenings at a proximal end region of the internal sheath, wherein eachside opening opens into an internal lumen of the multi-lumen catheter;and a crimping region at a proximal end region of the internal sheaththat is configured to be crimped to seal the one or more lumens afteruse to prevent contamination during removal of the internal sheath fromwithin the lumen of the endoscope.

Any of the endo scope sheath devices described herein (or method ofmaking and using them and/or system including them) may be configured toprevent contamination of an endoscope and may include: an externalsheath; a cap sealingly coupled to a distal end of the external sheath;and an internal sheath comprising a multi-lumen catheter extendingwithin the external sheath, wherein the internal sheath is sealinglycoupled to the cap so that the lumen of the multi-lumen catheter areopen through the cap; and a sealing region at a proximal end region ofthe internal sheath that is configured to seal the lumen of themulti-lumen catheter after use to prevent contamination during removalof the internal sheath from within a lumen of the endoscope. Asmentioned, any of these methods may include a plurality of radiallyspaced-apart side openings at a proximal end region of the internalsheath, wherein each side opening opens into an internal lumen of themulti-lumen catheter. The proximal end region of the internal sheath maybe configured to mate with a port adapter to create isolated ports influid connection with each lumen of the multi-lumen catheter. Thesealing region may comprise a crimping region (e.g., a mechanicalsealing/crimping region) configured to be mechanically crimped. Thus,the sealing region may be configured to be pressure sealed. The sealingregion may be configured to be heat sealed.

For example, an endoscope sheath device configured to preventcontamination of an endoscope, may include: a flexible external sheath;a cap sealingly coupled to a distal end of the external sheath; and aninternal sheath comprising a multi-lumen catheter extending within theexternal sheath, wherein the internal sheath is sealingly coupled to thecap so that the lumen of the multi-lumen catheter are open through thecap, further wherein the internal sheath is configured to extend througha lumen of the endoscope; and a crimping region at a proximal end regionof the internal sheath that is configured to be crimped to seal the oneor more lumens after use to prevent contamination during removal of theinternal sheath from within the lumen of the endoscope.

An endoscope sheath device configured to prevent contamination of anendoscope may include: a flexible external sheath configured to extendover the endoscope; a cap sealingly coupled to a distal end of theexternal sheath; and an internal sheath comprising a multi-lumencatheter extending within the external sheath, wherein the internalsheath is sealingly coupled to the cap so that the lumen of themulti-lumen catheter are open through the cap, further wherein theinternal sheath is configured to extend through a lumen of theendoscope; a plurality of radially spaced-apart side openings at aproximal end region of the internal sheath, wherein each side openingopens into an internal lumen of the multi-lumen catheter; and a crimpingregion at a proximal end region of the internal sheath that isconfigured to be crimped to seal the one or more lumens after use toprevent contamination during removal of the internal sheath from withinthe lumen of the endoscope.

Also described herein are methods of making any of the endoscope sheathsdescribed herein. For example, a method of making an endoscope sheathdevice configured to prevent contamination of an endoscope may include:sealing a distal end region of a tubular internal sheath to an openingthrough a cap that is configured to couple to a distal end region of theendoscope, wherein the tubular internal sheath is configured to beinserted through a lumen of the endoscope; and sealing a distal endregion of a tubular external sheath to the cap, wherein the tubularexternal sheath is configured to fit over an outer surface of theendoscope. In general a tubular external sheath and/or a tubularinternal sheath may have any cross-sectional shape, not limited tocircular or oval (e.g., square, triangular, octagonal, etc.).

Any of these methods may include coating the inside (and in someexamples the outside) of the internal sheath or sheaths with ahydrophilic coating, as any of these apparatuses may include an internalsheath with a hydrophilic coating on the inside of the full length ofthe internal sheath and/or on the outside of the internal sheath. Insome examples, the method may include coating a sheet of an internalsheath material with a hydrophilic coating and forming the sheet ofinternal sheath material into a tube to form the tubular internal sheathso that the hydrophilic coating extends within a lumen of the tubularinternal sheath. In some examples the hydrophilic coating is applied asan additive to a matrix material. The internal sheath with the coatingmay be a single-lumen sheath (e.g., a working channel liner) or amulti-lumen sheath. For example, any of these methods may includesealing a distal end region of a second tubular internal sheath to asecond opening through the cap, wherein the second tubular internalsheath comprises a multi-lumen tube. In some examples the tubularinternal sheath may comprise a working channel liner having a workingchannel lumen.

Any of the apparatuses (e.g., sheaths) described herein may include areinforced internal sheath or sheaths, in particular at the distal endregions of the internal sheath(s). This may be particularly helpful invariations in which the distal end region (e.g., the distal tip region)of the catheter is configured to be bent, steered, etc. Thus, it may bebeneficial to provide an apparatus having a reinforced distal end region(or all of the length of the endoscope or just the distal end region,such as the distal 5 cm, distal 4 cm, distal 3 cm, distal 2 cm, distal 1cm, etc. Reinforcing the distal end region of the single-lumen internalsheaths (e.g., working channel liner) may be particularly helpful toprevent pinching closed at the bending distal end region. Thus, any ofthe methods of forming the apparatuses described herein may also includereinforcing the tubular internal sheath so that the distal end region ofthe tubular internal sheath is prevented from collapse when bending.

In any of these examples the internal sheath may include a reinforcingstructure such as a reinforcing coil; thus the method of forming theapparatus may include adding a reinforcing coil. In some example themethod may include adding a reinforcing just the distal end region(e.g., just to the distal 5 cm, distal 4 cm, distal 3 cm, distal 2 cm,distal 1.5 cm, distal 1 cm, etc.).

In any of these methods sealing the distal end region of the tubularinternal sheath to the cap and sealing the distal end region of thetubular external sheath may comprise forming a continuousfluid-impermeable contamination barrier.

Any of these methods may include packaging the endoscope sheath devicein a coiled configuration. This configuration may make it easier tostore and apply the sheath device onto an endoscope, including taking upless space and less landfill, and reducing any necessary sterilizationcosts.

Any of these methods may include forming a crimping region at a proximalend region of the internal sheath (or each of the sheaths in variationswith multiple sheaths) that is configured to be crimped to seal the oneor more lumens after use to prevent contamination during removal of theinternal sheath from within a lumen of the endoscope. In some examples,the crimping region may include a cuff or ring formed of a relativelyductile material, such as a metal, that may be pinched closed to sealthe one or more lumens of the internal sheath(s). In some example, theinternal sheath may include a region formed of a material that may becrimped as described herein.

The methods of forming the devices described herein may also includeruggedizing the tubular external sheath. The tubular external sheath maybe formed to be shorter than the tubular internal sheath (e.g., theinternal sheath(s) may extend beyond the tubular external sheath). Thedevices described herein may be formed using any of the caps describedherein, including caps that are all or partially transparent. The capmay include a cylindrical mating surface having an oval configuration atrest, wherein the cylindrical mating surface is configured to becompressed to assume a circular cross-sectional configuration to fitover a distal end of an endoscope. Any of these methods may includeattaching a proximal attachment on the tubular external sheath that isconfigured to secure the tubular external sheath to an outer surface ofthe endoscope.

For example, a method of making an endoscope sheath device configured toprevent contamination of an endoscope may include: coating a layer of aninternal sheath material with a hydrophilic coating and laminating theinternal sheath material into a tubular internal sheath so that thehydrophilic coating extends within a lumen of the tubular internalsheath; sealing a distal end region of the tubular internal sheath to anopening through a cap that is configured to couple to a distal endregion of the endoscope, wherein the tubular internal sheath isconfigured to be inserted through a lumen of the endoscope; and sealinga distal end region of a tubular external sheath to the cap, wherein thetubular external sheath is configured to fit over an outer surface ofthe endoscope, wherein the tubular external sheath, the cap and thetubular internal sheath form a continuous fluid-impermeablecontamination barrier.

For example, a method of making an endoscope sheath device configured toprevent contamination of an endoscope may include: reinforcing a tubularinternal sheath, including with a higher density of reinforcementdistally so that a distal end region of the tubular internal sheath isprevented from collapse when bending; sealing a distal end region of theinternal sheath to an opening through a cap that is configured to coupleto a distal end region of the endoscope, wherein the internal sheath isconfigured to be inserted through a lumen of the endoscope; and sealinga distal end region of a tubular external sheath to the cap, wherein theexternal sheath is configured to fit over an outer surface of theendoscope, wherein the external sheath, cap and internal sheath form acontinuous fluid-impermeable contamination barrier.

As mentioned above, any of these sheath apparatuses may include a distalcap configured to couple to the endoscope that that include one or morelight sources. These light sources may be light emitting diodes (LEDs),fiber optics, laser light sources, etc. For example, described hereinare endoscope sheath devices configured to prevent contamination of anendoscope that include: an external sheath; a cap sealingly coupled to adistal end of the external sheath, wherein the cap is at least partiallytransparent and configured to couple to a distal end of the endoscope;(optionally) one or more internal sheaths each extending within theexternal sheath, wherein each internal sheath has one or more internallumens, further wherein each internal sheath is sealingly coupled to thecap so that the one or more internal lumens is open through the cap; andone or more light sources on the cap configured to project lightdistally of the cap.

In some examples the one or more light sources comprises alight-emitting diode (LED). For example, the one or more light sourcesmay include a red light source, a green light source and a blue lightsource. The apparatus may be configured to apply white light, e.g., byilluminating each of the red, green and blue, light sources, and/orapplying a specific wavelength or range of wavelengths (e.g., red orgreen or blue) to interrogate the anatomy differentially using differentwavelengths of light. The one or more light sources may include aplurality of light sources arranged at least partially around aperimeter of the cap. The light sources may be arranged around the fullperimeter or portion of the perimeter. In some examples the apparatusmay include a plurality of conductive members (e.g., traces, wires,etc.) coupled to the one or more light sources on the cap and extendingon or in the external sheath or on or in the internal sheath. Forexample, wires may extend helically around the external sheath to couplewith a control and/or power on the proximal end of the device.

In some examples the apparatus includes one or more electrical contactson an inner surface of the cap, wherein the one or more electricalcontacts are in electrical communication with the one or more lightsources. The electrical contacts may be on an inner surface of the capand may be pads or pins that contact pins or pads on the distal endregion of the endoscope.

In general, the cap may include a lensing region configured to bepositioned over a camera of the endoscope. The lensing region may beformed in the cap (of the cap material) and/or it may include anadditional material added to the cap. The lensing region may be a lensformed as a concave and/or convex region. The lensing region may expandthe field of view.

In general, the cap is configured to be secured to the distal end of thecatheter. For example, the cap may include one or more of: a frictionfitting configured to secure the cap to the distal end of the endoscope,a snap fit configured to secure the cap to the distal end of theendoscope, a magnet configured to secure the cap to the distal end ofthe endoscope, a bayonet connector configured to secure the cap to thedistal end of the endoscope, or a threaded region configured to securethe cap to the distal end of the endoscope. In some examples the cap mayinclude a cylindrical engagement region that fits over the endoscope andmay include one or more latches.

For example, described herein are endoscope sheath devices configured toprevent contamination of an endoscope, the device comprising: a flexibleand tubular external sheath; a cap sealingly coupled to a distal end ofthe external sheath, wherein the cap is at least partially transparent;a tubular elongate internal sheath extending within the external sheathand having one or more internal lumens, further wherein a distal endregion of the tubular elongate internal sheath is sealingly coupled tothe cap so that the one or more internal lumens of the tubular elongatesheath is open through the cap; and one or more light sources on the capconfigured to project light distally of the cap.

An endoscope sheath device configured to prevent contamination of anendoscope may include: a flexible and tubular external sheath; a capsealingly coupled to a distal end of the external sheath, wherein thecap is at least partially transparent; a tubular elongate internalsheath extending within the external sheath and having one or moreinternal lumens, further wherein a distal end region of the tubularelongate internal sheath is sealingly coupled to the cap so that the oneor more internal lumens of the tubular elongate sheath is open throughthe cap; one or more light sources on the cap configured to projectlight distally of the cap; and one or more electrical contacts on aninner surface of the cap, wherein the one or more electrical contactsare in electrical communication with the one or more light sources.

Any of the sheath apparatuses described herein may be configured asrigidizing sheaths. For example, described herein are rigidizing sheathsin which the external sheath is rigidizing and may be transitioned froma flexible configuration to a rigid configuration, e.g., by theapplication of pressure; in some examples positive pressure may beapplied, in some examples negative pressure may be applied, and in someexamples either positive or negative pressure may be applied.

The rigidizing sheath devices described herein can transition from aflexible configuration to a rigid configuration. In some examples, e.g.,based on the pressure applied, the rigidity (e.g., the stiffness) may beconsidered “variable stiffness” as it may be selected by the user orsystem. For example, a rigidizing external sheath may be rigidized byapplying a positive or negative pressure to rigidize a rigidizing layerwithin the rigidizing external sheath by driving a compression layer(e.g., bladder) against a rigidizing layer, preventing or limitingmovement of the rigidizing layer. With the positive or negative pressureremoved (or reversed), the layers can easily shear or move relative toeach other; the release of the positive or negative pressure may allowthe layers to transition to a condition in which they exhibit asubstantially enhanced ability to resist shear, movement, bending,torque and buckling, thereby providing system rigidization. Although theexamples described herein primarily illustrate rigidizing by theapplication of pressure (e.g., positive or negative pressure), themethods and apparatuses described herein may be used with anyappropriate rigidizable sheath(s), not limited to positive or negativepressure rigidizing apparatuses. For example, the rigidizable sheath asdescribed herein may refer to any appropriate rigidizing sheath,including sheaths that may be rigidized by jamming particles, by phasechange and/or shape memory alloys, by interlocking components (e.g.,cables with discs or cones, etc.), EAP (electro-active polymers) or anyother rigidizing mechanism.

Any of the rigidizable sheaths described herein may include rigidizinglayers or regions that engage with a compression layer (which may be ormay include a bladder) that applies force to the rigidizing layer torigidize the rigidizing layer or in some cases to de-rigidize (e.g.,release from rigidization) the rigidizing layer. In some examples, theserigidizable apparatuses may include a rigidizing layer that couldinclude a braid, knit, woven, chopped segments, randomly distributed orrandomly oriented filaments or strands, engagers, links, scales, plates,segments, particles, granules, crossing filaments, or other materialsforming the rigidizing layer. For example, the rigidizing layer maycomprise multiple strand lengths or strand segments that cross over eachother (e.g., as part of a braid, knit, woven, etc.); the compressionlayer may apply force to drive the crossing strand lengths or strandsegments against each other. Although many of the examples shown hereinare braids, any of these apparatuses may instead or in addition includea general rigidizing layer comprising crossing strand lengths or strandsegments. The examples of rigidizing apparatuses described herein mayuse pressure (positive pressure) and/or negative pressure to selectivelyand controllable rigidize. In some examples the method described hereinmay be used with any appropriate rigidizing apparatus. Examples ofrigidizing structures that may be included as part of a rigidizingsheath may include those described in PCT application PCTUS2023064999,filed Mar. 27, 2023 and titled “METHODS AND APPARATUSES FOR NAVIGATINGUSING A PAIR OF RIGIDIZING DEVICES,” U.S. patent application Ser. No.17/902,770, titled “NESTED RIGIDIZING DEVICES,” filed on Sep. 8, 2022,U.S. patent application Ser. No. 18/000,062, titled “RIGIDIZINGDEVICES,” filed on May 26, 2021, patent application no. PCTUS2022014497,titled, “DEVICES AND METHODS TO PREVENT INADVERTENT MOTION OFDYNAMICALLY RIGIDIZING DEVICES,” filed on Jan. 31, 2022, patentapplication no. PCTUS2022082300, titled “METHODS AND APPARATUSES FORREDUCING CURVATURE OF A COLON,” filed on Dec. 22, 2022, patentapplication no. PCTUS2023062206, titled “DYNAMICALLY RIGIDIZINGCOMPOSITE MEDICAL STRUCTURES,” filed on Feb. 8, 2023. Each of theseapplications are herein incorporated by reference in their entirety.

For example, an endoscope sheath device configured to preventcontamination of an endoscope may include: a rigidizing external sheathconfigured to extend over the endoscope, the rigidizing external sheathincluding: a rigidizing layer comprising multiple strand lengths thatcross over each other, and a compression layer that is configured to beactuated to apply force to the rigidizing layer to rigidize therigidizing external sheath from a flexible configuration to a rigidconfiguration; a cap configured to couple to a distal end of theendoscope, wherein the cap is sealingly coupled to a distal end regionof the external sheath; an internal sheath extending within therigidizing external sheath and configured to extend through a lumen ofthe endoscope, wherein the internal sheath has one or more internallumens and is sealingly coupled to the cap so that the one or moreinternal lumens of the internal sheath is open through the cap.

As mentioned, in some examples, the rigidizing layer may includemultiple strand lengths that cross over each other. The multiple strandlengths may comprise one or more of: a braid, a knit, a weave, choppedsegments, randomly distributed and/or randomly oriented filaments, orengagers. The compression layer may comprise a bladder. The internalsheath may be less flexible than the flexible configuration of therigidizing external sheath. Any of these apparatuses may include apressure port coupled to the rigidizing external sheath and configuredto receive pressure to actuate the compression layer. The rigidizingexternal sheath may be configured to rigidizing by the application ofpositive pressure. The rigidizing external sheath may be configured torigidizing by the application of negative pressure.

For example, an endoscope sheath device configured to preventcontamination of an endoscope, may include: a rigidizing external sheathconfigured to extend over the endoscope, the rigidizing external sheathincluding: a rigidizing layer comprising multiple strand lengths thatcross over each other, and a compression layer that is configured to beactuated to apply force to the rigidizing layer to rigidize therigidizing external sheath from a flexible configuration to a rigidconfiguration; a cap sealingly coupled to a distal end region of theexternal sheath and configured to engage a distal end of the endoscope;and an internal sheath extending within the rigidizing external sheathand configured to extend through a lumen of the endoscope, wherein theinternal sheath has one or more internal lumens and is sealingly coupledto the cap so that the one or more internal lumens of the internalsheath is open through the cap.

Any of the apparatuses described herein may be configured to bereinforced, and in particular the internal sheath(s) may be reinformedat their distal ends, in order to prevent pinching of the one or morelumens of the tubular internal sheath(s). Endoscopes may be steerableand may therefore bend at their distal end region. Thus, the sheathapparatuses described herein may be configured to prevent, reduce orminimize the impact of the internal sheath(s) on the overallflexibility, and therefore steering, of the distal ends of theapparatuses. In some examples the internal sheath(s) may be configuredto be relatively flexible. However, these internal sheaths may also beconfigured to resist pinching of the lumen when bending or flexing,which may otherwise occur with highly flexible structures. For example,the internal sheaths described herein may be reinforced, e.g., by areinforcing coil, etc., to prevent collapse while maintaining a highdegree of flexibility.

For example, an endoscope sheath device configured to preventcontamination of an endoscope may include: a cap configured to couple toa distal end of the endoscope; a flexible external sheath configured toextend over the endoscope, wherein a distal end region of the externalsheath is sealingly coupled to the cap; and a tubular internal sheathconfigured to be inserted through a lumen of the endoscope, the tubularinternal sheath extending proximally from the cap and within theexternal sheath, wherein a distal end region of the tubular internalsheath is sealingly coupled to the cap so that a lumen of the tubularinternal sheath is open through the cap, further wherein the distal endregion is of the tubular internal sheath is reinforced to prevent thetubular internal sheath from collapsing when bending.

The distal end region of the tubular internal sheath may comprise areinforcing coil. In some examples just the distal end region of thetubular internal sheath is reinforced; alternatively the majority (orall) of the length of the internal sheath may be reinforced. In someexamples, where multiple internal sheaths are used, only those internalsheaths having a single lumen (e.g., a working channel liner) arereinforced as described herein. For example, any of these apparatusesmay include a second tubular internal sheath sealingly coupled to thecap and configured to be inserted through a lumen of the endoscope, thesecond tubular internal sheath extending proximally from the cap andwithin the external sheath. The second tubular internal sheath maycomprise a multi-lumen catheter. This second tubular internal sheath maynot be reinforced.

The tubular internal sheath may include a working channel liner having aworking channel lumen. The working channel lumen may include ahydrophilic coating. The flexible external sheath, cap and tubularinternal sheath may form a fluid-impermeable contamination barrier toprevent contamination of the endoscope.

For example, an endoscope sheath device configured to preventcontamination of an endoscope may include: a cap configured to couple toa distal end of the endoscope; a flexible external sheath configured toextend over the endoscope, wherein a distal end region of the externalsheath is sealingly coupled to the cap; and a tubular internal sheathcomprising a working channel liner that is configured to be insertedthrough a lumen of the endoscope, the tubular internal sheath extendingproximally from the cap and within the external sheath, wherein a distalend region of the tubular internal sheath is sealingly coupled to thecap so that a lumen of the tubular internal sheath is open through thecap, further wherein the distal end region is of the tubular internalsheath is reinforced to prevent the tubular internal sheath fromcollapsing when bending, wherein the flexible external sheath, cap andtubular internal sheath form a fluid-impermeable contamination barrierto prevent contamination of the endoscope.

For example, an endoscope sheath device configured to preventcontamination of an endoscope, the device may include: a cap configuredto couple to a distal end of the endoscope; a flexible external sheathconfigured to extend over the endoscope, wherein a distal end region ofthe external sheath is sealingly coupled to the cap; and a first tubularinternal sheath comprising a working channel liner that is configured tobe inserted through a lumen of the endoscope, the tubular internalsheath extending proximally from the cap and within the external sheath,wherein a distal end region of the tubular internal sheath is sealinglycoupled to the cap so that a lumen of the tubular internal sheath isopen through the cap, further wherein the distal end region is of thetubular internal sheath is reinforced to prevent the tubular internalsheath from collapsing when bending; and a second tubular internalsheath comprising a multi-lumen catheter that is sealingly coupled tothe cap and configured to be inserted through a lumen of the endoscope,the second tubular internal sheath extending proximally from the cap andwithin the external sheath, wherein the flexible external sheath, capand the first and second tubular internal sheaths form a barrier toprevent contamination of the endoscope during use.

In any of the methods and apparatuses described herein the capconfigured to couple to the distal end of the apparatus may be aremovable cap that is configured to be squeezed between two fingers tofit over the distal end of the endoscope and may be squeezed to removefrom the distal end of the endoscope. For example, an endoscope sheathdevice may include: a tubular external sheath configured to extend overthe endoscope; a tubular internal sheath configured to extend within alumen of the endoscope, the tubular internal sheath having one or morelumens; and a cap configured to couple to a distal end of the endoscope,wherein a distal end region of the tubular external sheath is sealed tothe cap, and further wherein a distal end region of the internal sheathis sealed to the cap so that the one or more lumens of the tubularinternal sheath is open through the cap, wherein the cap is configuredto be removed by squeezing two sides of the cap. The cap may include asubstantially cylindrical mating surface configured to mate with adistal end of the endoscope when compressed from an oval restingcross-sectional configuration into a substantially circular matingcross-sectional configuration. These caps may include a stress-reliefcut-out region configured to decrease the force necessary to transitionthe cylindrical mating surface to the circular mating cross-section.

As used herein a substantially cylindrical surface may haveapproximately parallel sides (e.g., may deviate by a percentage, such as+/−10%, 9%, 8%, 7%, 6%, 5%, etc.). A substantially circularcross-sectional configuration may be approximately circular, and neednot be perfectly circular, e.g., the radius may vary by a percentagearound the circumference of the cross-section (e.g., by about +/−10% orless, 9% or less, 8% or less, 7% or less, 6% or less, 5% or less, etc.).Thus, when a cap is compressed from an oval resting cross-sectionalconfiguration into a substantially circular mating cross-sectionalconfiguration, the cap may be compressed from an oval restingcross-sectional configuration into mating cross-sectional configurationthat is more circular than the oval resting configuration, but may stillbe somewhat oval.

In general, the cap may include one or more of: a snap fit, a frictionfit, a magnet coupler, a bayonet connector or a threaded region. Any ofthese caps may include a latching connector configured to secure the capto the distal end region of the endoscope. The latching connector mayinclude an opening in the cap configured to engage with a projection onthe distal end reign of the endoscope. Alternatively or additionally thelatching connector may include a projection that mates with an openingon the endoscope.

In some examples the endoscope sheath device configured to preventcontamination of an endoscope includes: a cap configured to couple to adistal end of an endoscope; an external sheath sealingly coupled at adistal end to the cap; and one or more internal sheaths extending withinthe external sheath, wherein each internal sheath is sealingly coupledat a distal end to the cap and opens through the cap.

For example, an endoscope sheath device may include: a tubular externalsheath configured to extend over the endoscope; a tubular internalsheath configured to extend within a lumen of the endoscope, the tubularinternal sheath having one or more lumens; and a cap configured tocouple to a distal end of the endoscope, wherein a distal end region ofthe tubular external sheath is sealed to the cap, and further wherein adistal end region of the internal sheath is sealed to the cap so thatthe one or more lumens of the tubular internal sheath is open throughthe cap, wherein the cap comprises a cylindrical mating surfaceconfigured to mate with a distal end of the endoscope when compressedfrom an oval resting cross-sectional configuration into a circularmating cross-sectional configuration; and a latching connectorconfigured to secure the cap to the distal end region of the endoscope,wherein the flexible external sheath, cap and the first and secondtubular internal sheaths form a fluid-impermeable contamination barrierto prevent contamination of the endoscope during use.

An endoscope sheath device may include a tubular external sheathconfigured to extend over the endoscope; a first tubular internal sheathconfigured to extend within a first lumen of the endoscope, the firsttubular internal sheath having one or more lumens; a second tubularinternal sheath configured to extend within a second lumen of theendoscope; and a cap configured to couple to a distal end of theendoscope, wherein a distal end region of the tubular external sheath issealed to the cap, and further wherein a distal end region of each ofthe first internal sheath and the second internal sheath are sealed tothe cap so that the one or more lumens of the tubular internal sheath isopen through the cap, wherein the cap comprises a cylindrical matingsurface configured to mate with a distal end of the endoscope whencompressed from an oval resting cross-sectional configuration into acircular mating cross-sectional configuration; and a latching connectorconfigured to secure the cap to the distal end region of the endoscope,wherein the flexible external sheath, cap and the first and secondtubular internal sheaths form a fluid-impermeable contamination barrierto prevent contamination of the endoscope during use.

As mentioned above, also described herein are systems that may includeany of the devices described herein. In particular, described herein aresystems including a catheter adapted for use with a sheath as describedherein. These catheters may include a handle region configured to passthe internal sheath(s). For example, described herein are endoscopesystems including a fluid-impermeable contamination barrier to preventcontamination of an endoscope, the system comprising: an endoscopehaving a lumen and a handle; and an endoscope sheath device comprising:an external sheath configured to extend over the endoscope, an internalsheath comprising one or more lumens, the internal sheath configured toextend through the lumen of the endoscope, and a cap configured tocouple to a distal end of the endoscope, wherein a distal end region ofthe external sheath is sealed to the cap, and further wherein a distalend region of the internal sheath is sealed to the cap so that one ormore lumens of the internal sheath is open through the cap; and amanifold block removably coupled to the handle of the endoscope, whereinthe manifold block comprises one or more valves in fluid communicationwith the lumen of the endoscope, wherein the internal sheath isconfigured to engage with the manifold block so that the one or morevalves control passage of fluid through the one or more lumens of theinternal sheath.

The internal sheath may comprise a multi-lumen catheter, and/or maycomprise a single-lumen sheath (e.g., a working channel liner).

Any of these systems may include a port adapter configured to mate withthe multi-lumen catheter to create isolated ports in fluid connectionwith each lumen of the multi-lumen catheter. These methods may include asealing device configured to seal the one or more lumens of the internalsheath. The endoscope sheath device may further comprise a secondexternal sheath configured to extend through a second lumen of theendoscope, wherein a distal end region of the second internal sheath issealed to the cap so that one or more lumens of the second internalsheath is open through the cap. The manifold block may comprise a lumenconnection configured to engage with the second lumen of the internalsheath. In some of these examples the manifold block is disposable. Themanifold block may further comprise an umbilical linking the one or morevalves of the manifold block to one or more connectors configured tocouple to one or more of: a source or irrigation fluid, a source of air,and a source of vacuum.

Any of the sheath apparatuses (devices, systems, etc.) may optionally beused with a robotic endoscope, as described, including nested roboticendoscopes. The sheath devices described herein may be applied over aninner endoscope member (e.g., an inner rigidizing endoscope) before itis coupled with an outer endoscope member (e.g., a mother device or anovertube), so that the external sheath covers just the inner member, andthe outer member may be separately cleaned or sterilized. In someexamples the sheath device may be attached to the inner endoscope memberafter it is coupled with the outer endoscope member, so that theflexible external sheath may cover both the inner and outer endoscopes.

For example, a system comprising an elongate outer tube for use with aninner endoscope in a telescoping arrangement may include: an elongateouter tube, the elongate outer tube comprising an outer tube lumen; anexternal sheath coupled to a proximal end region of the elongate outertube at a first end region; a cap sealingly coupled to a second end ofthe external sheath; and an internal sheath having one or more internalsheath lumen and extending within the external sheath and within theouter tube lumen, wherein the internal sheath is sealingly coupled tothe cap so that the one or more internal sheath lumen is open throughthe cap. The cap may be configured to couple to a distal end of theinner endoscope and the internal sheath is configured to extend througha lumen of the inner endoscope. The elongate outer tube may beconfigured to be selectively rigidized, e.g., by applying positivepressure or negative pressure.

Also described herein are methods and apparatuses for inflating orcollapsing the external sheath of the endoscope sheath device configuredto prevent contamination of an endoscope. For example, any of theseapparatuses may include a flexible tubular external sheath that isconfigured to be collapsed against the endoscope by applying suction(e.g., negative pressure) between the flexile tubular external sheathand the outside of the endoscope. The sheath device may be configured tomaintain a seal between the flexible external sheath and the endoscope.In some examples the apparatus and/or method may be configured to applypositive pressure between the flexible tubular external sheath and theoutside of the scope, e.g., to inflate the flexible external sheath.This may help anchor, navigate and/or secure the endoscope within thebody. Both collapsing (e.g., applying negative pressure) and inflating(e.g., applying positive pressure) may be helpful for indicating thatthe sheath device is maintaining a fluid-impermeable contaminationbarrier relative to the body.

For example an endoscope sheath device may include: a flexible tubularexternal sheath configured to extend over the endoscope; a capconfigured to couple to a distal end of the endoscope, wherein a distalend region of the flexible tubular external sheath is sealed to the cap;and a proximal sealing collar, wherein a proximal end region of theflexible tubular external sheath is sealed to the proximal sealingcollar, further wherein the proximal sealing collar is configured toform an airtight seal against the endoscope, so that the tubularexternal sheath may be inflated or deflated by the application of fluidpressure (e.g., air pressure, saline pressure, etc.) between theflexible tubular external sheath and the outer surface of the endoscope.Any of these apparatuses may include a pressure port in fluidcommunication with an inner region of the flexible tubular externalsheath and configured to apply positive or negative pressure between theflexible tubular external sheath and the outer surface of the endoscope.For example, a pressure port on the proximal sealing collar may beconfigured to apply positive or negative pressure between the flexibletubular external sheath and the outer surface of the endoscope. Theflexible external sheath may comprise an elastomeric material. Theflexible external sheath may have a non-uniform diameter along thelength of the flexible external sheath. In some examples the flexibleexternal sheath has one or more inflation regions along the length ofthe flexible external sheath configured to expand to a larger expandedradius when the flexible external sheath is inflated by the applicationof positive pressure.

The cap may be configured to seal to the distal end of the endoscope. Insome examples the cap is configured to secure to the distal end of theendoscope and comprises one or more of: a friction fitting configured tosecure the cap to the distal end of the endoscope, a snap fit configuredto secure the cap to the distal end of the endoscope, a magnetconfigured to secure the cap to the distal end of the endoscope, abayonet connector configured to secure the cap to the distal end of theendoscope, or a threaded region configured to secure the cap to thedistal end of the endoscope.

Any of these devices may include a tubular internal sheath configured toextend within a lumen of the endoscope, the tubular internal sheathhaving one or more lumens, wherein a distal end region of the internalsheath is sealed to the cap so that the one or more lumens of thetubular internal sheath is open through the cap.

For example, an endoscope sheath device may include: a flexible tubularexternal sheath configured to extend over the endoscope; a tubularinternal sheath configured to extend within a lumen of the endoscope,the tubular internal sheath having one or more lumens; a cap configuredto couple to a distal end of the endoscope, wherein a distal end regionof the flexible tubular external sheath is sealed to the cap, andfurther wherein a distal end region of the internal sheath is sealed tothe cap so that the one or more lumens of the tubular internal sheath isopen through the cap; and a proximal sealing collar, wherein a proximalend region of the flexible tubular external sheath is sealed to theproximal sealing collar, further wherein the proximal sealing collar isconfigured to form an airtight seal against the endoscope, so that thetubular external sheath may be inflated or deflated by the applicationof fluid pressure between the flexible tubular external sheath and theouter surface of the endoscope. In some examples the fluid pressure maybe applied as air pressure. Alternatively other gas (e.g., carbondioxide, etc.) or liquids (e.g., saline) may be used.

Also described herein are methods and apparatuses for confirming that anendoscope is uncontaminated after use. In general, these methods mayinclude pressurizing the endoscope sheath device to confirm that theexternal sheath is not compromised, as might occur if it is torn orruptured. For example, a method may include: performing a medicalprocedure in a body with the endoscope while the endoscope is ensheathedwithin an endoscope sheath device; withdrawing the endoscope from thebody; applying positive pressure between the endoscope and an externalsheath of the endoscope sheath device; and indicating, based on a decayof pressure from between the external sheath and the endoscope, if theendoscope sheath device is contaminated or not contaminated.

The procedure may be performed using any of the apparatuses describedherein. For example, performing may comprise performing the medicalprocedure wherein the endoscope is ensheathed so that an outer surfaceof the endoscope is enclosed by the external sheath of the endoscopesheath device and an inner lumen of the endoscope is covered by aninternal sheath, wherein the external sheath and the internal sheathform a continuous fluid-impermeable barrier.

The pressure may be applied from a pressure port on the endoscope orseparate from the endoscope. In some examples the proximal end of theexternal sheath may include a port for applying pressure. Any of thesemethods may include applying positive pressure between the endoscope andan external sheath of the endoscope sheath device by at least partiallyinflating the external sheath. In any of these methods a proximalportion of the external sheath may be sealed to a proximal region of theendoscope. In any of these apparatuses and methods, a distal end ofendoscope sheath device (e.g., the cap and/or the distal end region ofthe external sheath) may be configured to seal to the distal end regionof the endoscope.

Indicating may include determining if the external sheath has developeda leak based on a decay of pressure from between the external sheath andthe endoscope. The pressure may be monitored by a pressure sensorcoupled to the pressure port or the applied pressure source, and/or theendoscope sheath device. In some examples a pressure indicator (e.g.,gauge, sensor, dial, etc.) may be included. In some cases the method mayinclude manually observing the inflated external sheath to detect a lossof pressure (indicating leak and possible contamination).

In general, indicating may comprise emitting a signal. Alternatively oradditionally, indicating may include transmitting the signal (e.g., thepressure profile, pressure signal, and/or a processed signal based onthe pressure signal) to a remote processor for storage, furtherprocessing and/or presentation to the user or a third party. In someexamples indicating includes emitting an alert if the decay of pressurefrom between the external sheath and the endoscope exceeds a threshold,e.g., audible and/or visible alert.

For example, a method of confirming that an endoscope is uncontaminatedmay include: performing a medical procedure with an endoscope while adistal end of the endoscope is covered by a cap, wherein an internalsheath that is sealingly connected to the cap extends through a lumen ofthe endoscope from a distal end to a proximal end and so that one ormore internal sheath lumen extends through the lumen of the endoscopeand are open through the cap, further wherein an external sheath issealingly connected to the cap and extends proximally over theendoscope; withdrawing the endoscope from the body; applying positivepressure between the endoscope and an external sheath of the endoscopesheath device; and indicating, based on a decay of pressure from betweenthe external sheath and the endoscope, if the endoscope sheath device iscontaminated or not contaminated.

Any of the apparatuses and methods described herein may include anapplicator for applying and/or removing the endoscope sheath device ontoand/or off of the catheter. For example, any of these methods andapparatuses may include an installing handle. The installing handle mayinclude an internal region for holding the external sheath of the devicein a compressed or folded (e.g., pleated, accordion folded, scrunched,etc.) configuration for deployment. The same installing handle may beused to remove and invert the external sheath once the procedure hasbeen completed. For example a system including an installing handle maybe configured as an endoscope sheath apparatus to prevent contaminationof an endoscope, the apparatus comprising: a cap configured to couple toa distal end of an endoscope; an external sheath sealingly coupled at adistal end to the cap; one or more internal sheaths extending within theexternal sheath, wherein each internal sheath is sealingly coupled at adistal end to the cap and opens through the cap; and an installinghandle, wherein at least a portion of the external sheath is held in agathered configuration within a chamber of the installing handle,further wherein the one or more internal sheaths extend distally throughthe gathered external sheath and chamber and out of a distal end of theinstalling handle.

The cap may be positioned at a distal end of the installing handle. Theinstalling handle may include a coupler at the proximal end of theinstalling handle configured to couple to a matching attachment on theendoscope. The external sheath may be held in the gathered configurationwithin the chamber so that the external sheath is compressed. In someexamples the external sheath is held in the gathered configurationwithin the chamber so that a distal end of the catheter may fit withinthe external sheath when inserted from the distal end of the installinghandle. The installing handle may comprise an outer gripping surface. Insome examples the installing handle comprises a cylindrical shape. Theexternal sheath may be gathered in a bellows (e.g., circular orcylindrically pleated) configuration.

The installing handle may include a distal-facing conical surface on adistal end of the installing handle. This distal-facing conical surface(e.g., funnel shape) may help capture any waste within the invertingexternal sheath and may help guide the external sheath to invert overitself when removing the external sheath from the endoscope.

Also described herein are methods of installing an endoscope sheathdevice onto an endoscope, the method comprising: inserting an internalsheath through a lumen of an endoscope from a distal end of theendoscope; advancing the distal end of the endoscope through an externalsheath that is held in a gathered configuration within an installinghandle; coupling a cap of the endoscope sheath apparatus to a distal endregion of the endoscope; and pulling the installing handle proximallyover the endoscope to deploy the external sheath over the endoscope. Anyof these methods may include coupling the installing handle to theendoscope and/or removing the endoscope sheath device from the endoscopeby advancing the installing handle distally over the endoscope to invertthe external sheath over itself proximally.

In general, as described above, any method for removing the endoscopesheath device may include sealing a proximal end region of the internalsheath before withdrawing it (or them) from the lumen(s) of theendoscope. For example, the one or more internal sheaths may be sealedat a proximal sealing region that is configured to be sealed bymechanically sealing (e.g., crimping), by heat sealing, etc. Any ofthese methods may further include disengaging the cap from the endoscopeand pulling the sealed internal sheath from out of the lumen of theendoscope.

All of the methods and apparatuses described herein, in any combination,are herein contemplated and can be used to achieve the benefits asdescribed herein.

BRIEF DESCRIPTION OF THE DRAWINGS

A better understanding of the features and advantages of the methods andapparatuses described herein will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,and the accompanying drawings of which:

FIGS. 1A-1C schematically illustrate an example of a generic endoscopethat may be used with the apparatuses and methods described herein.

FIGS. 2A-2C schematically illustrate an example of a telescopingassembly including an endoscope that may be used with the apparatusesand methods described herein.

FIGS. 3A-3C schematically illustrate examples of endoscope sheaths asdescribed herein. FIG. 3A shown an example having a relatively shortexternal sheath that may be secured to the distal end region of an outertube. FIG. 3B shows an example including a proximal attachment on theexternal sheath. FIG. 3C shows an example having a long external sheaththat may extend beyond the length of the outer tube and/or endoscopemember.

FIGS. 4A-4C schematically illustrate examples of endoscope sheaths shownattached to a telescoping (e.g., mother/child) endoscope assembly.

FIGS. 5A-5C show an example of an endoscope sheath attached to atelescoping endoscope assembly.

FIG. 6A schematically illustrates an example of a telescoping endoscopeassembly.

FIG. 6B schematically illustrates an example of a telescoping endoscopeassembly with a partial sheath.

FIG. 7A schematically illustrates an example of a cap of a sheathassembly shown en face. FIG. 7B is an example of a section through anexample of an endoscope. FIG. 7C shows a section through one example ofa sheath assembly.

FIGS. 7D and 7E show side sectional views through one example of asheath assembly of FIG. 7C coupling to the endoscope of FIG. 7B.

FIGS. 8A-8B illustrate the use of an example of a port adapter manifoldfor coupling to a multi-lumen catheter (of an internal sheath) asdescribed herein.

FIG. 9A schematically illustrates an example of a port adapter manifoldengaging with a multi-lumen catheter. FIG. 9B shows a section throughthe port adapter manifold of FIG. 9A, which is similar to that shown inFIGS. 8A-8B.

FIGS. 9C-9D show examples of port adapter manifolds that may be used asdescribed herein.

FIG. 9E is a sectional view through one example of a port adapterincluding a connector (e.g., a tuohy connector) for securing and sealinga multi-lumen catheter (e.g., an internal sheath configured as amulti-lumen catheter) as described herein.

FIGS. 10A-10C illustrate one example of sealing a proximal end of aninternal sheath.

FIG. 11 is a section through one example of a multi-lumen catheter thatmay be used as an internal sheath as described herein.

FIG. 12 is an example of a port adapter for coupling to a proximal endof a multi-lumen catheter forming an internal sheath.

FIG. 13 shows an example of a port adapter for coupling to a proximalend of a multi-lumen catheter forming an internal sheath.

FIG. 14 illustrates a proximal end of an internal sheath including acrimping region to seal off the internal sheath before removing theendoscope from the sheath assembly.

FIGS. 15A-15D illustrate an example of a system including an endoscope(FIG. 15A), a sheath device (FIG. 15B), and an outer endoscope (FIG.15D).

FIGS. 16A-16B illustrate a system including a sheath device, a separateouter rigidizing device and external working channels. FIG. 16B shows aschematic illustration of the system illustrating the use of theexternal working channels.

FIGS. 17A-17D illustrate an example of a system including an endoscope(FIG. 17A), a rigidizing sheath device (FIG. 17B), and an outerendoscope (FIG. 17D).

FIG. 18 illustrates an example of a sheath over an endoscope having asteerable distal end region.

FIGS. 19A-19B illustrate examples of internal sheaths that arereinforced over a portion or all of their length.

FIGS. 20A-20D illustrate an example of a cap for an endoscope sheathdevice. FIG. 20A shows a front view, FIG. 20B shows a side perspectiveview, FIG. 20C shows a side view and FIG. 20D shows a back view of thecap.

FIGS. 21A and 21B shows a distal end region of an endoscope configuredto receive the cap of the sheath device shown FIGS. 20A-20D. FIG. 21A isa distal end view of the endoscope and FIG. 21B is a perspective view.

FIG. 21C shows an end view of the endoscope shown in FIGS. 21A-21B witha cap similar to that shown in FIGS. 21A-21B attached to the distal endregion of the catheter.

FIGS. 22A-22C illustrate an example of an endoscope sheath device havinga cap including a plurality of LED light sources integrated therein. Theendoscope sheath device is shown attached to an endoscope. IN FIG. 22Athe device and endoscope are shown in a front perspective view. FIG. 22Bshows a front (end) view, and FIG. 22C shows a side view.

FIGS. 23A and 23B illustrate an example of a cap of an endoscope sheathdevice that is transparent and includes a plurality of LED lightsarranged thereon.

FIGS. 24A and 24B illustrate examples of caps including multi-lumenextrusions holding the wires for controlling (e.g., powering) theintegrated LEDs on the cap.

FIG. 25 schematically illustrates a cap including a plurality of LEDS ofdifferent wavelengths (e.g., colors) that may be controlled toilluminate in different colors or color combinations.

FIGS. 26A-26B illustrate attaching one example of a cap for an endoscopesheath; for convenience the inner and external sheath are not shown.

FIGS. 27A-27C illustrate one example of a method of disengaging a cap ofan endoscope sheath device, which may be part of the method of removingthe endoscope sheath device.

FIGS. 28A-28D schematically illustrate another example of a method forapplying a cap of an endoscope sheath device which may be part of themethod of applying the endoscope sheath device to an endoscope.

FIGS. 29A-29B schematically illustrate a method of mating a cylindricalmating surface of a cap of an endoscope sheath device with a distal endof the endoscope by compressing the sides of the cylindrical matingsurface of the cap to transition the cap from an oval restingcross-sectional configuration into a circular mating cross-sectionalconfiguration.

FIGS. 30A-30B show an example of a transparent cap for an endoscopesheath device similar to that shown in FIGS. 29A-29B.

FIGS. 31A-31B illustrate operation of the multi-lumen internal sheathand cap for an endoscope sheath device. FIG. 31A is a perspective viewand FIG. 31B is a front (end) view illustrating the application of eachof insufflation, wash fluid and irrigation fluid using the multi-lumeninternal sheath, while maintaining the sterility of the endoscopecovered by the endoscope sheath device.

FIGS. 32A-32B illustrate the endoscope sheath device of FIGS. 31A-31Bdelivering a wash fluid to wash the optics of the cap in a sideperspective view (FIG. 32A) and a sectional view (FIG. 32B). In FIGS.32A-32B the tip wash fluid is shown as a cylindrical stream forconvenience; actual tip wash fluid may assume a different shape as it ispassed over the tip.

FIGS. 33A-33B illustrate the endoscope sheath device of FIGS. 31A-31Bdelivering insufflation from the cap in a side perspective view (FIG.33A) and a sectional view (FIG. 33B). In FIGS. 33A-33B the insufflationis shown as a flattened triangle for convenience; actual insufflation(e.g., a gas such as air) may assume a different shape as it is passedover the tip.

FIGS. 34A-34B illustrate the endoscope sheath device of FIGS. 31A-31Bdelivering an irrigation fluid from the cap in a side perspective view(FIG. 34A) and a sectional view (FIG. 34B). In FIGS. 34A-34B theirrigation fluid is shown as a cylindrical stream for convenience;actual irrigation fluid may assume a different shape as it is emittedfrom the tip.

FIG. 35A illustrates one example of a port adapter that may be used witha multi-lumen catheter forming an internal sheath. In FIG. 35A the portadapter is shown partially transparent and engaged with an internalsheath.

FIGS. 35B-35D show examples of end views of the (transparent) portadapter of FIGS. 35A, illustrating the separation of ports for each ofirrigation fluid (FIG. 35B), wash fluid (FIG. 35C) and insufflation(FIG. 35D).

FIGS. 36A and 36B illustrate examples of a cap for an endoscope sheathdevice that includes an integrated optical lens as part of the cap. FIG.36A shows a front (end) view and FIG. 36B shows a side sectional viewthrough the cap of FIG. 36A.

FIGS. 37A-37C illustrate removable components (e.g., scope caps) thatmay be used with any of the endoscope sheath devices described herein.FIGS. 37A and 37B show side perspective views with the scope cap off andon, respectively, the distal end of the endoscope sheath device appliedover an endoscope. FIG. 37B shows a side sectional view.

FIG. 38 shows an example of an endoscope sheath device with anintegrated (e.g., molded or overmolded) end cap.

FIG. 39A illustrates an example of a prior art endoscope.

FIG. 39B schematically illustrates an example of a manual endoscopeadapted for use with an endoscope sheath as described herein.

FIGS. 40A-40C illustrate examples of an endoscope sheath device in whichthe external sheath may be inflated and/or collapsed (e.g., deflated).FIG. 40A schematically illustrates an example of a catheter. FIG. 40Bschematically illustrates an example of an endoscope sheath deviceconfigured to form proximal seal to the endoscope so that the externalsheath may retain positive or negative pressure. FIG. 40C schematicallyillustrates the endoscope sheath device coupled (and sealed to) theendoscope.

FIG. 41A schematically illustrates an example of an endoscope sheathdevice coupled (and sealed to) the endoscope. The tubular externalsheath of the endoscope sheath device has a uniform profile along thelength of the sheath, and is shown with a tube that can be used toassist in installation of the endoscope, allowing the external sheath tobe vacuum expanded (outward) during installation.

FIG. 41B schematically illustrates an example of an endoscope sheathdevice (having a tapered profile) coupled (and sealed to) the endoscope.

FIG. 41C schematically illustrates an example of an endoscope sheathdevice coupled (and sealed to) the endoscope. The tubular externalsheath of the endoscope sheath device has a stepped-down profile alongthe length of the sheath.

FIG. 42 schematically illustrates an example of an endoscope sheathdevice coupled (and sealed to) the endoscope after the application ofnegative pressure, showing the tubular external sheath vacuumed downagainst the outer surface of the endoscope.

FIGS. 43A-43B are schematic illustrations of examples of endoscopesheath devices coupled (and sealed to) an endoscope in which positivepressure has been applied between the external sheath and the endoscopeto inflate the tubular external sheath. In FIG. 43A the external sheathincludes a single expandable (e.g., balloon) region, while in FIG. 43Bthe external sheath has a pair of expandable (e.g., balloon) regions.

FIG. 44 is a schematic illustration of an example of an endoscope sheathdevice configured to evert over itself for removal from the endoscopeafter use.

FIG. 45 illustrates the problem of buckling of an endoscope (e.g.,catheter) when advancing within a tortious anatomy.

FIGS. 46A-46B illustrate the use of an endoscope sheath device to deploy(e.g., advance) an endoscope member as described herein. In FIG. 46A theinner (nested) endoscope is coupled to sheath at the distal end and thecover extends over the inner and outer endoscopes; applying positivepressure between the external sheath and the endoscopes causes theexternal sheath to deploy distally, driving the inner endoscopedistally, as shown in FIG. 46B.

FIG. 47 illustrate another example of an endoscope sheath deviceincluding an inflatable sheath applied to a nested endoscope.

FIG. 48 is similar to FIG. 45 and illustrates the use of an inflatableendoscope sheath device to help guide the positioning of the endoscopewithin the tortuous anatomy.

FIG. 49 schematically illustrates an example of an inflatable endoscopesheath used in which the endoscope includes a sensor (e.g., ultrasoundsensor).

FIGS. 50A-50C illustrate one example of an endoscope sheath apparatus(e.g., endoscope sheath device) including an installing handle. FIG. 50Ashows a side view of one example of an endoscope sheath apparatusincluding an installing handle in a pre-deployed configuration. FIG. 50Bshows the endoscope sheath apparatus of FIG. 50A in a top frontperspective view and FIG. 50C shows the same endoscope sheath apparatusin a rear side perspective view.

FIGS. 51A-51D illustrate one example of a method of applying anendoscope sheath apparatus over an endoscope as described herein, usingan installing handle.

FIGS. 52A-52B show a back (proximal) view of an endoscope sheathapparatus including an installing handle, showing coupling of theinstalling handle to the proximal end of the endoscope.

FIG. 53 illustrate an example of a method of packaging an endoscopesheath apparatus as described herein. Illustrating the compact, coiledconfiguration.

FIGS. 54A-54C illustrate removal of an endoscope sheath apparatus froman endoscope using an installing handle.

FIG. 55 schematically illustrates one method of making an endoscopesheath apparatus as described herein.

DETAILED DESCRIPTION

In general, described herein are endoscope sheath assemblies (e.g.,endoscope sheath devices and system) including a cap configured tocouple to the distal end of the endoscope, an external sheath thatextends over the endoscope (and optionally seals to or covers an outerelongate member coaxially over the endoscope), and one or more internalsheath(s) that extend within one or more lumens of the endoscope. Boththe external sheath and the internal sheath are configured to seal tothe cap. These apparatuses may be configured to prevent contamination ofthe endoscope without inhibiting any of the functions of the endoscope,including the ability of the endoscope to pass material into or out thedistal end of the endoscope through an internal lumen or working channeland/or imaging from the distal end of the endoscope and/or movingrelative to an outer elongate member.

Any of these apparatuses may be used with an endoscope that is coaxiallyarranged within a rigidizing overtube (outer elongate member). Either orboth the outer elongate member and the endoscope may be configured torigidize. Any appropriate rigidization may be used, including, but notlimited to rigidization by applying positive and/or negative pressure.In general the rigidizing members described herein can transition from aflexible configuration (i.e., one that is relaxed, limp, or floppy) to arigid configuration (i.e., one that is stiff and/or holds the shape itis in when it is rigidized). The apparatuses and methods describedherein may be particularly well suited for use with rigidizing devicesbut may be used with non-rigidizing devices. In some examples, arigidizing member (also referred to equivalently as a rigidizing device,a selectively rigidizing device or a selectively rigidizing member) mayinclude a plurality of layers (e.g., coil or reinforced layers, sliplayers, braided layers, bladder layers and/or sealing layers) that cantogether form the wall of a rigidizing member. The rigidizing memberscan transition from the flexible configuration to the rigidconfiguration, for example, by applying a positive or negative pressureto the wall of the rigidizing device or within the wall of therigidizing device. With the positive or negative pressure removed, thelayers can easily shear or move relative to each other. With the vacuumor pressure applied, the layers can transition to a condition in whichthey exhibit substantially enhanced ability to resist shear, movement,bending, torque and buckling, thereby providing system rigidization.Examples of rigidizing members that may be used with any of the devicesand methods described herein may include (but are not limited to) thosedescribed, for example in described in international patent applicationNo. PCT/US2016/050290, filed Sep. 2, 2016, titled “DEVICE FOR ENDOSCOPICADVANCEMENT THROUGH THE SMALL INTESTINE,” international patentapplication No. PCT/US2016/050290, filed on Sep. 2, 2016, titled “DEVICEFOR ENDOSCOPIC ADVANCEMENT THROUGH THE SMALL INTESTINE,” published as WO2017/041052, international patent application No. PCT/US2018/042946,filed on Jul. 19, 2018, titled “DYNAMICALLY RIGIDIZING OVERTUBE,”published as WO 2019/018682, international patent application No.PCT/US2019/042650, filed on Jul. 19, 2019, titled “DYNAMICALLYRIGIDIZING COMPOSITE MEDICAL STRUCTURES,” published as WO 2020/018934,international patent application No. PCT/US2020/013937 filed on Jan. 16,2020, titled “DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES,” andPCT/US2021/034292, filed on May 26, 2021, entitled “RIGIDIZING DEVICES.”Each of these application is herein incorporated by reference in itsentirety.

Any appropriate rigidizing member may be used, including rigidizingmembers that are not formed of layers and/or actuated by pressure(positive and/or negative pressure). For example, the rigidizing membersdescribed herein may refer to any appropriate rigidizing device,including members that may be rigidized by jamming particles, by phasechange and/or shape memory alloys, by interlocking components (e.g.,cables with discs or cones, etc.), EAP (electro-active polymers) or anyother rigidizing mechanism.

As mentioned, the sheath assemblies described herein may be used withone or more robotic systems, including telescoping, rigidizing roboticsystem as described, for example, in U.S. patent application Ser. No.17/152,706 (titled “DYNAMICALLY RIGIDIZING COMPOSITE MEDICALSTRUCTURES,” now U.S. Pat. No. 11,135,398), U.S. patent application Ser.No. 17/493,785 (titled “DYNAMICALLY RIGIDIZING COMPOSITE MEDICALSTRUCTURES”), and international patent applications no.PCT/US2021/034292 (titled, “RIGIDIZING DEVICES”) and PCT/US2021/024582(tiled “LAYERED WALLS FOR RIGIDIZING DEVICES”), each of which is hereinincorporated by reference in its entirety.

The endoscope sheath assemblies described herein may be used with asingle endoscope. An endoscope may refer to an elongate instrument whichcan be introduced into the body and may include one or more lumensextending therethrough and may be used for examining, treating and/ordiagnosing an interior region of a body. Any of these endoscopes mayinclude imaging (e.g., typically by a CCD, CMOS chip, or fiber opticmaterial) to give a view from the distal end of the device. Theendoscope may generally be a catheter including one (or more than one)internal lumen extending the length of the endoscope. For example, inFIG. 1A, the endoscope 100 includes an elongate flexible (or in someexamples, selectively rigidizable) body that extends from a distal end113 to a proximal end 111. The endoscope includes a first lumen 105(e.g., a working channel) and a second lumen 107 and a camera 109. Thefirst lumen may be a working channel through which one or more tools maybe inserted or/or manipulated for acting on tissue at the distal end ofthe endoscope within the body. The second lumen may be, e.g., a suction,a fluid (air, water, etc.) application lumen, or the like. The lumen(e.g., the internal working channel) may extend the length of theendoscope. The endoscope may be any appropriate length and width and maygenerally be formed of a biocompatible material. FIG. 1B shows across-section through the endoscope of FIG. 1A, and FIG. 1C shows adistal end view of the endoscope of FIG. 1A.

FIGS. 2A-2C illustrate an example of an assembly including an innerendoscope 201 that is coaxially arranged within an outer tube 203. Theendoscope 201 may be similar or identical to the endoscope shown inFIGS. 1A-1C, and include one or more internal lumens 105, 107 (e.g.,working channel 105) and may be configured to slide axially 220 withinthe outer tube 203. FIG. 2B show a section through the assembly of FIG.2A and FIG. 2C shows a distal end view of the assembly of FIG. 2A. Insome examples the assembly may be a telescoping assembly including theendoscope 201 and the outer tube 203 configured to be flexible but maybe selectively rigidized. An endoscope or endoscope assembly such asthose shown schematically in FIGS. 1A-1C and 2A-2C may be used with anyof the endoscope sheaths (sheath devices) described herein.

FIGS. 3A-3C illustrate examples of endoscope sheaths as describedherein. The sheaths illustrated in FIGS. 3A-3C are shown unattached orunconnected to either an endoscope or an endoscope assembly (e.g., anouter tube and an inner endoscope member). In FIG. 3A for example theendoscope assembly 300 includes a cap 327 that is configured to secureto and over a distal end region of an endoscope. For example, the cap327 may snap onto the distal end, e.g., the cap may connect to thedistal end of the catheter by a deflectable snap on either the cap, thedistal end of the endoscope, or both. For example, the cap may include abendable or flexing member to releasably lock (e.g., by a “snap fit”)the cap onto the distal end of the endoscope. In some examples the capmay secure (releasably secure) to a distal end of an endoscope by aclamping or spring-loaded mechanism. In some examples the cap may coupleby engaging a screw-on or threaded region. In some examples the cap 327may couple by a friction fit (e.g., the cap may include one or moreshear surfaces that are configured to secure the cap to the distal endof the endoscope). In some examples the cap may couple magnetically tothe distal end region of the scope to secure the cap to the distal end.In some examples the cap may be secured to the distal end of the scopeby a bayonet connector.

In FIG. 3A an external sheath 302 is shown sealing connected (e.g.,fused, welded, integrally formed, etc.) to the cap 327. The externalsheath may be flexible and in particular may be sufficiently thin orthin-walled that it may be lightweight and may move relative to theouter tube (not shown) as the endoscope moves in and out of the outertube and/or rotates relative to the outer tube. The example shown inFIG. 3A includes a single internal sheath 315 extending proximallywithin the external sheath, and sealing connected to the cap 327. Thesealing connection between the cap and the internal sheath is such thatthe internal lumen of the internal sheath is open to the body so thatfluids may be applied through the endoscope without compromising thebarrier between the patient and the endoscope. In FIGS. 3A-3C theinternal sheath forms only a single lumen is shown in this example, inother examples multiple lumen structures may be used, such multi-lumencatheters. Thus, as shown in FIG. 3A the internal sheath may form anopening 315′ through the cap that is continuous with the internal sheath315 shown.

In this example the external sheath 302 is shorter than the internalsheath 315, and the internal sheath 315 extends proximally 331 from outof the external sheath. In some examples, a short external sheath maycouple to an outer tube (not shown in FIG. 3A) such as an overtube, andmay seal to the outside so that the outer tube may act with the externalsheath to protect the endoscope extending within the outer tube.

FIG. 3B illustrates another example of an endoscope sheath device 300′(e.g., sheath assembly) similar to that shown in FIG. 3A, but with asecond internal sheath 317, having a distal opening 317′ through the cap327 that may pass material or tools into and out of the endoscope totreat tissue. In FIG. 3B the second internal sheath 317 may form aworking channel liner that may line the working channel of theendoscope. The internal sheaths may be catheters, including multi-lumencatheters. The external sheath 315 in FIG. 3B may be similar to thatshown in FIG. 3A and may be relatively short, e.g., may couple to anouter tube (not shown). In any of these sheath assemblies describedherein the external sheath may include a proximal attachment on theexternal sheath configured to secure the external sheath to an outersurface of an outer tube that is coaxially arranged over the endoscope.

FIG. 3C shows a sheath assembly 300″ similar to that shown in FIG. 3B,including a first internal sheath 315 that opens 315′ through the cap327 and a second internal sheath 317 (e.g., working channel liner) thatalso opens 317′ through the cap 327, both sealingly attached to the cap,and an external sheath 302′ that is elongate and sealingly coupled tothe cap at a distal end and may optionally include a proximal attachmentregion or proximal attachment 321 for attaching to either the endoscopeor an outer tube that is configured to coaxially fit over the endoscope.

In any of these examples the cap may be clear (transparent) to allowimaging through or may include a window region configured to align witha camera region of an endoscope. In some examples, the cap has ananti-reflective or anti-glare coating.

FIGS. 4A-4C schematically illustrate examples of sheath assemblies showncoupled to endoscopes and outer tubes that are coaxially arranged overthe endoscopes to allow telescoping movement between the endoscope andouter tube.

In any of these apparatuses the sheath assembly may include the outertube, which may therefore be a single-use component that may be coupledto the external sheath. For example, FIG. 4A shows a section through asheath apparatus configured as a system including a flexible outer tube403 for use with an inner endoscope 401 in a telescoping arrangement. Inthis example the elongate outer tube 403 is coupled (e.g., sealinglycoupled 428) at a distal end region to an external sheath 402. Theexternal sheath 402 is in turn sealingly coupled 429 to a cap 427 at thedistal end of the external sheath. The cap 427 may then removablycoupled to the endoscope 401 at the distal end of the endoscope. Theexternal sheath 402 may be sealingly coupled around the outer perimeterof the cap, as shown. A pair of internal sheaths 415, 417 having one ormore internal sheath lumen extend within the external sheath and withina lumen of the endoscope 401. The internal sheaths both sealingly coupleto the cap so that the internal sheath lumen are open through the cap toallow material to pass through the endoscope. For example, one of theinternal sheath lumen may connect to a water supply and the other mayconnect to a suction and/or may provide a working channel, e.g., fortools.

In this example, the outer tube may be connected to the sheath tip witha thin flexible external sheath which permits substantial movement ofthe sheath tip both away and towards the distal tip of the outer tube,e.g., allowing axial (reciprocating) and well as torsional (‘roll axis’)movement even with the external sheath. The internal working channelsand supply lines of the endoscope contain the liner (e.g., internalsheaths) that are essentially long tubes the length of the endoscope sothat the endoscope lumen sheathed with the internal sheaths thatfunction as the tubes that deliver gasses and liquids or as the internalworking channel through which surgical tools or suction vacuum may bedelivered. The internal sheaths and external sheath are joined togetherat the cap (e.g., the sheath tip 427). The cap provides a transparentface for the endoscope's camera and illumination light, and may alsoincorporate nozzles (e.g., an exit for tip washing) and pass-throughports for the contents of the internal sheaths to be delivered throughthe cap. As mentioned, the cap may be configured to fasten to theendoscope tip so that it remains well attached during procedures but canthen be decoupled to change out the sheath assembly. The combination ofthe outer tube sealed to the external sheath, the external sheath sealedto the cap, and the cap sealed to the internal sheaths therefore fullyisolates the endoscope from the patient.

FIG. 4B shows the sheath assembly 400 of FIG. 1 without the endoscope401, including the attached outer tube 403, cap 427, and the pair ofinternal sheaths 415, 417. The sheath assembly 400 may releasably coupleto the endoscope, e.g. by inserting the internal sheaths 415, 417through lumen of the endoscope and snapping or otherwise coupling thecap 427 to the distal end of the endoscope.

FIG. 4C shows an alternative example, similar to that shown in FIG. 3C,in which the external sheath 402 is not coupled to the outer tube 403,and extends proximally along much or all (or more than) the length ofthe outer tube 403. As shown in this example, the external sheath 402extends proximally to the proximal end region of the endoscope and/orouter tubes.

FIGS. 5A-5C illustrate an example of an external sheath 502 attached toan outer tube 503, and includes two internal sheaths 517, 515 (shownsticking out of the proximal end of the outer tube 503 in FIG. 5A). Theexternal sheath in the device shown in FIGS. 5A-5C includes a base 522at the proximal end of the external sheath that may seal to the outerendoscope 503 (e.g., overtube). The outer tube in this example is shownshorter than normal but is representative of the full-length version.The cap 527 of the sheath assembly is coupled to the distal end of theexternal sheath 502. In FIG. 5A the sheath assembly is not yet coupledto an endoscope. FIG. 5B shows an endoscope 501 inserted into the outertube 503 with the endoscope 501 extended fully to the limit of theexternal sheath 502. The tip (cap 527) of the external sheath fastens tothe distal end region of the endoscope and extends and retracts with theendoscope as described above.

FIG. 5C shows the endoscope 501 protected within the external sheath 502and fully retracted into the outer tube 503 with the external sheath tip527 still attached to the endoscope tip. Note that the external sheath502 bunches up and does not restrict the retraction or extension orbending of the endoscope.

In operation, the configuration of the sheath assembly incorporating theouter tube as shown in FIGS. 5A-5C may be a one-time use and/ordisposable. In this example, the endoscope may be inserted through theouter tube and fully into the external sheath and attached to the sheathtip. The outer tube and/or the endoscope in the example may beselectively rigidizing devices that are actuated by the application ofpositive pressure or negative pressure. In this example, after theendoscope, outer tube and internal sheaths are connected to externalcontrol, vacuum and supply lines, the system is ready to be used in aprocedure, e.g., inserted into a body. The sheath may protect theendoscope 501 from contacting any material that may contaminate theendoscope. After the procedure, the internal sheaths and the outer tubemay both be disconnected from the rest of the system and removed fromthe endoscope and then discarded. The endoscope can then receive a newsheath which incorporates a new outer tube with internal and theexternal sheaths and be immediately re-used. No high-level disinfectionof the endoscope is required between procedures, which saves time andexpense. As described herein, the removal process may include sealingthe internal sheaths to prevent contamination.

In any of these apparatuses and method, after using the sheath assembly(e.g., endoscope sheath device), it can be pressure tested to confirmthat it has remained leak-free and that the underlying structures (e.g.,endoscope) therefore remains clean. To do so, the external sheath can beinflated at least partially, e.g., by injecting pressurized air througha pressure port. The external sheath may be sealed at either or bothends. The internal sheath can be sealed (for example, proximally, as itexits the liners). The method or apparatus may monitor pressure, e.g.,using a pressure sensor configured to detect pressure within theexternal sheath when inflated. The pressure sensor may track a pressuredecay curve that may be reported and/or analyzed to determine if thereis a leak, suggesting contamination. The pressure data may be reportedto the operator and/or the apparatus may automatically orsemi-automatically determine if there is a leak based on the pressuredata. For example the apparatus may include software, hardware and/orfirmware to receive pressure data configured to analyze the pressuredata (e.g., decay curve), compare the pressure response to predeterminedvalues to determine if there is a leak.

In some examples the external sheath extends the entire length of theouter tube, and the outer tube is not incorporated into the externalsheath, as described in FIG. 4C. In this configuration, the outer tubeis also fully isolated from contamination and can be reused with a newsheath without needing to be disinfected.

FIG. 6A shows a schematic example of a telescoping assembly, includingan outer tube 603 and endoscope 601 shown without a sheath assemblyattached. In contrast to the sheath assemblies described above, FIG. 6Bshows an example of a system including only a partial external sheathportion 672 that is coupled between the outer tube 603 and endoscope601, but does not include a cap or internal sheaths. In this example,although the space between the endoscope 601 and outer tube 603 may bekept fee of contamination, the outer surface of the outer tube and theinner lumen of the endoscope may both become contaminated.

As mentioned above, any appropriate cap may be used. For example, FIG.7A illustrates one example of a cap 727 shown in an end-on view. The capmay be formed of a clear material, such as clear polymeric material(e.g., polycarbonate (PC), polymethylmethacrylate (PMMA), acrylic,polyethylene terephthalate (PET), polyvinyl chloride (PVC), polyethylene(PE), cyclic olefin copolymer (COC), etc.). In some examples, as shownin FIG. 7A, a transparent camera window region 736 may be included. Thecap may also include a sealed junction 739 to the fixed internal sheath(“fixed sleeve”) such as a multi-lumen extrusion sheath 717 and/or aworking channel sheath 715. The insides of these internal sheaths areopen, as shown, to allow access to the body region at the distal end ofthe apparatus. For example, the multi-lumen extrusion sheath 717includes three sub-lumen 737, 738, 738′, e.g., a lumen for water 737,for air 738, and/or for vacuum 738′ (or an additional air/waterchannel). In FIG. 7A the working channel sheath also include an openchannel 748 that may be used to pass tools through the endoscope.

FIG. 7B shows a section through a distal end region of one example of anendoscope 701 that may be used with a sheath assembly as describedherein. In FIG. 7B the endoscope 701 includes an internal lumen 785 thatextends the length of the endoscope and opens at the distal end of theendoscope. FIG. 7C shows a sectional view through an example of a sheathassembly 700 including a cap 727, an external sheath 702, an interiorsheath 717 that is configured as a multi-lumen 738, 737 extrusionsheath. The external sheath 702 may be coupled to an elongate outer tube(not shown in FIG. 7C) or may be long enough to extend down the fulllength of a separate elongate outer tube and/or endoscope.

FIGS. 7D-7E illustrate the application of the sheath assembly 700 ofFIG. 7C over the endoscope 701 of FIG. 7B. The proximal end of theinterior sheath 717 may be first inserted into the internal lumen 785 ofthe endoscope and the endoscope may be advanced distally 749 until thecap 727 of the sheath assembly 700 can couple to the endoscope 701. Forexample, FIG. 7D shows a sectional view through the distal end region ofthe sheath assembly 700 with the endoscope 701 partially inserted. Theexternal sheath 702 of the sheath assembly is sealed around the outsideof the cap 727, and the internal sheath 717 is also sealed to the insideof the cap 727. As mentioned, the internal sheath 717 in this examplehas two lumen 738, 737 that open through the cap so that material (e.g.,air, water, saline, etc.) may pass into or out of the lumen of thesheath, through the endoscope without contaminating the lumen of theendoscope 701. The cap 727 in this example is optically transparent atleast over the camera window region 736, although in some examples theentire cap may be transparent, so that the imaging camera 786 of theendoscope 701 may image through the cap 727.

In FIG. 7D the sheath assembly is shown with the cap 727 not yetconnected to the endoscope 701. The endoscope 701 may be driven distally749 (or alternatively and/or additionally the cap may be drivenproximally) to engage with the cap 727, as shown in FIG. 7E. In thisexample recessed region 714 at the distal end region of the endoscopemay engage with a connector 716 (e.g., a deformable or deflectableconnector) on the cap to secure the cap to the distal end of theendoscope, as shown in FIG. 7C. The recessed region 714 may be a cavityand/or it may be a lip, ridge or rim. In some examples the connector mayinclude a shear surface configured to secure the cap to the distal endof the endoscope, a magnet configured to secure the cap to the distalend of the endoscope, a bayonet connector configured to secure the capto the distal end of the endoscope, a threaded region configured tosecure the cap to the distal end of the endoscope, or the like. Becausethe connection occurs within the external sheath or between the externalsheath and the internal sheath(s), this connection does not need to forma seal, but should be secure so that as the endoscope is moved axiallyand/or in rotation, the cap remains at the distal end of the endoscope.

As mentioned above, in order to prevent contamination of the endoscopeand/or the outer tube, in any of these example apparatuses describedherein, the internal sheaths (e.g., working channels, multi-lumencatheters, etc.) may be sealed before they are removed from theendoscope (and in some cases the outer tube). This can be done inseveral ways. For example the one or more internal sheaths (which may beconfigured as catheters) may be plugged, crimped, blocked by an adhesiveor other plug, heat sealed, etc. The sealing methods used may staywithin the outside diameter of the internal sheath so that it can bewithdrawn through the endoscope. For example, see FIGS. 10A-10C and 14 .

The apparatuses described herein may incorporate internal workingchannels and supply lines into the disposable sheath. This mayeffectively make those elements of an endoscope disposable one-time-useelements which protects the patient as well as the endoscope equipment.As mentioned, these working channels (working channel liners) may besealed before their removal.

In general, these sheath apparatuses described herein are configured sothat the endoscope and the outer tube may roll relative to each other inaddition to sliding axially. In some examples the external sheath can beintentionally torqued as it accommodates the rotation of one relative tothe other. Movement of the inner endoscope and/or outer tubes may bedone manually or robotically, and the sheath assemblies described hereinmay advantageously accommodate a variety of both longitudinal/axialmovement as well as rotational movement between the inner endoscope andouter tubes.

Also described herein are port adapters for the easy fluid connectivityto small-bore, multi-lumen catheters (extrusions) that may be used asinternal sheaths (working channel liners). For example, FIG. 11illustrates a cross section of one example of an internal sheath(multi-lumen extrusion, MLE) 1117 that incorporates a working channel1116 with 3 other water/gas channels 1118, 1119, 1120 into a singleextrusion. Thus, in some configurations, only one internal sheath may beneeded.

A multi-lumen internal sheath such as that shown In FIG. 11 may be usedwith a port adapter to allow access to all of the internal lumen withinthe internal sheath. Some of the lumens may connect in one direction(i.e., out the side), and some may connect in other directions (forexample, axially or in-line). In any of these apparatuses and methodsthe proximal end of the multi-lumen catheter may be sealed, but one ormore openings into the lumens may arranged along the sides of the distalend region, e.g., for mating with a port adapter, as described herein.In some examples the port adapter may instead be configured to couplewith and access the distal end of the multi-lumen catheter forming theinternal sheath (e.g., inner liner), for example, forming seals with theindividual lumens of the multi-lumen catheter. Note that any of the portadapters described herein may be configured for use with a single lumeninternal sheath (e.g., single-lumen catheter), by making a sealingcontact with the lumen of the internal sheath, either through a sideopening or at the distal end (or both).

Returning now to FIGS. 8A-8B, an internal sheath 817 configured as amulti-lumen extrusion (MLE) is shown with one example of a port adapter.In FIG. 8A, the internal sheath includes a rigid or semi-rigid connectortip 885 including lateral openings 808 into each of the lumen of theinternal sheath 817, shown attached to the proximal end 887 of theinternal sheath 817 at an optional joint 886. The joint may or may notbe necessary, i.e., 817 may have the exit holes without the need for asa separate connector tip 885. The proximal end may also include anengagement structure (e.g., neck region 889) that may engage with a portadapter, as shown in FIG. 8B. In FIG. 8B, the connector tip 885 of theinternal sheath 817 is inserted into a receptacle manifold of the portadapter 869 which provides connections for each lumen (or channel) inthe internal sheath, as shown in FIGS. 9A-9B. In this configuration, thesystem is not radially positionally dependent, i.e., it may be insertedsuch that any radial configuration properly ports to the mating lumens.Between each of the radial ports is a separating and sealing gasket(e.g., O-ring). Between each sealing gasket is a spacer ring thatpermits through-flow.

FIG. 9A show an example of connection of the internal sheath 817 into aport adapter 869 which provides individual passthrough connections toeach independent lumen in the multi-lumen catheter. In any of these portconnectors, the proximal end of the internal sheath may engage with theport connector to secure it in place, and/or to align the openings 808of the internal sheath with connectors of the port connector. In FIG. 8Athe port connector 869 includes an internal sheath connector receptaclewith a releasable locking mechanism 992 that engages with the engagementstructure 889 at the proximal end region of the internal sheath. Inalternative embodiments, 885 may have no special end geometry 889, andthere could be, for example, an angled metal tang that ‘grabs’ theoutside of the 885, serving to keep it retained. To remove, the tangcould be deflected out of the way, such that it no longer contacts 885.

FIG. 9B shows an example of a cross section of the port adapter of FIG.9A. In this example, the proximal end connector 885 of an internalsheath is inserted and latched into a receptacle manifold of a portadapter as shown in FIG. 9A. Flow from each lumen may be kept separateand passed through to individual ports 971, 972, 973 for connection tosupply lines. A three-channel implementation is shown, but more or fewerchannels (or lumens) could be accommodated using this technique.

In FIG. 9B, each individual port includes an annular sealing region 994(for example, by the use of O-rings 993, which create two or more radialseals. In between the O-rings 993 are spaces that transmit flow: forexample, rings with channels and cross-drilled geometry. When theinternal sheath 817 is secured in the port connector, the lateralopenings 808 into each lumen are aligned along the length of theproximal end so that they are positioned with an annular sealing regionspecific to each lumen. In FIG. 9B, the two annular sealing regions onthe right side of the figure are each aligned with an opening 808 in theinternal sheath. Thus, fluid may pass into or out of the opening fromthis annular sealing region that is fluid communication with a port 972,973 on the port connector 869. These ports may be standardized forfitting any appropriate connector.

FIGS. 9C and 9D illustrate two examples of port adapters 969, 969′before (FIG. 9C) and after (FIG. 9D) insertion of the multi-lumencatheter forming an internal sheath of an endoscope sheath device. InFIG. 9C, similar to that shown in FIG. 9A, the first port adapter 969 isconfigured so that the multi-lumen catheter 917 may be inserted into theinlet 966 and may easily slide all the way until the distal end of themulti-lumen catheter is reaches the back (e.g., a stop 988) in the portadapter, as shown by the cross-sectional view of FIG. 9E. In thisexample, the inside of the port adapter may be divided up into regionsor zones corresponding to the number of lumen in the multi-lumencatheter. The regions may be separated by one or more gaskets 983. Themulti-lumen catheter may include one or more openings or holes throughthe walls of the multi-lumen catheter into each of the lumen of themulti-lumen catheter that are arranged along the length, so thatopenings into a particular lumen of the multi-lumen catheter will fallwithin a particular range of distance from the end of the multi-lumencatheter so that, once inserted into the port adapter, all of the holescorresponding to the particular lumen will be within a correspondingregion or zone, as described in FIG. 9A.

Any of the port adapters (“port adapter manifolds”) described herein mayinclude one or more valves configured to control passage of fluidthrough the lumens of the multi-lumen catheter. Alternatively oradditionally each port adapters may include a plurality of fluid lineconnectors 991, 991′, 991″, wherein each connector is configured to becoupled to a fluid line (liquid fluid line, suction line, etc.).

As the multi-lumen catheter (e.g., a multi-lumen channel liner) enterthe receptacle manifold 970 of the port adapter, it may face highcompression loads as, to seal, the O-ring inner diameter would be lessthan the outer diameter of the multi-lumen catheter. Although such atight fit may help form the radial seals from the O-rings, this may leadto buckling of the multi-lumen catheter. The example port adapter 969shown in the top of FIGS. 9C and 9D and in cross-section in FIG. 9E mayavoid this problem by increasing the radial clearance of the O-rings andapplying force to squeeze the O-rings down by axially compressing thecomponent stack (e.g., the gasket stack), which translates into therequisite radial compression of the seals against the multi-lumencatheter. This motion (e.g., axial advancement by rotating a threadtranslating into a radial squeeze) is similar to what is done with adevice at the back of a catheter (typically to adjust the back-end sealagainst a guidewire) by a tuohy (e.g., a Tuohy Borst adapter).

In the port adapter 969 shown in FIGS. 9C-9E, the gaskets 983 forming aseal between each of these separate zones may be o-shaped rings thathave an inner diameter that may be larger than the outer diameter of themulti-lumen catheter. This may allow easy insertion of even veryflexible or multi-lumen catheters and may help ensure full insertion ofthe multi-lumen catheter. As shown in FIG. 9E the port adapter mayinclude a compression mechanism, such as a tuohy connector for securingthe multi-lumen catheter within the port adapter. For example, the knob913 may be twisted clockwise to compress the gaskets in the gasket stack(e.g., receptacle manifold) onto the multi-lumen catheter; tighteningthe knob drives a pusher 981 into the receptacle manifold (e.g., stack)of gaskets 983, axially compressing them and therefore radiallycompressing them 985, and tightening them over the multi-lumen catheter,forming seals. To remove the multi-lumen catheter, the knob 913 may beuntwisted to release the compressive force 985 applied by driving 986the pusher 981 into the gaskets of the receptacle manifold. In any ofthese devices and methods the port adaptor may be automated. Forexample, the port adapter may include one or more sensors so thatinsertion of the multi-lumen catheter could trigger a sensor at the end988 of the port adapter, which may then automatically turn the knob or,with a linear actuator, simply slide it axially, thereby compressing theO-rings and creating a seal.

FIGS. 9C and 9D also illustrate a port adapter 969′ similar to the portadapter 869 shown in FIGS. 9A-9B, which may include a catch or lock tosecure the multi-lumen catheter within the port adapter. In any of theport adapters described herein the device may include a sprung pawl orcatch-like means for securing the multi-lumen catheter within the portadapter. The port adapter may be one-way or releasable.

FIG. 12 illustrates an alternative port adapter 1269. In FIG. 12 , theport adapter uses a face seal strategy. A male connector 1212 insertedinto the female connector 1215. Each lumen in the male connector (threeof them in this illustration) is fed by its own separate supply channel.The supply channels seal to the end of the male connector via a faceseal so that there is no cross transmission between the channels. FIG.13 shows another example of this type of port adapter. In this example,the face of the multi-lumen extrusion internal sheath may align eachchannel with a port, which may require rotational orientation of theinput tube. In any of these examples, the shaft of the internal sheath1212 may be keyed to guide orientation of the internal sheath relativeto a port connector.

In FIG. 13 , the internal sheath 1317 engages with the port adapter 1369in a keyed manner so that the internal lumen may each engage a connectorin the port connector that may seal to opening at the distal end of theinternal sheath to permit access into and out of the lumen within theinternal sheath. In the example shown in FIG. 13 , the upper portconnector 1369 is shown engaged with the internal sheath 1317, while thelower port connector 1369′ is not engaged with an internal sheath 1317′.Each port connector includes three standard connectors 1368 that may becoupled to tubing for applying/removing material.

As mentioned above, before removal of the sheath assembly, the internalsheaths may be blocked to prevent contamination. The internal sheath(s)may be sealed off by any appropriate manner, including thermal (e.g.,melting with forces applied by heated dies), mechanical (e.g., crimping,pinching, stapling, etc.), or the like. FIG. 14 illustrates acrimp-based sealing method. A crimp 1442 may be included on the internalsheath, preferably near the proximal end region. This crimp 1442 may becrimped shut after a procedure. The compressed crimp 1442′ seals thesheath to prevent contaminated fluids from leaking out of the sheath,and when compressed the crimp is smaller in diameter than the outsidediameter of the internal sheath 1417, so that it can be pulled through.The internal sheath 1417 can then be wiped clean and removed by pullingit through the endoscope without contaminating the endoscope.

Returning now to FIGS. 10A-10C, these figures illustrate an alternativeto crimping in which an internal sheath 1015 is sealed by heat sealingafter a procedure. Heat sealing hygienically seals the internal sheathkeeping any contamination safely inside the sheath. Internal volume ofthe tube can locally be driven to zero, which greatly reduces thepotential for contamination. Heat sealing could further reduce anyproblem associated with any potential residual matter. In FIG. 10A theinternal sheath 1015 is inserted into the heat-sealing device 1042, sothat heat (and/or mechanical pressure) may be applied as shown in FIG.10B to melt the material of the internal sheath, resulting in a seal1016 as shown in FIG. 10C. After heat sealing, or as part of the heatsealing operation, the internal sheath can be cut and withdrawn backthrough the endoscope with no risk of contamination. Heat sealing oftubes with liquids in them is routinely done for blood sampling andother applications.

The use of internal sheaths for the sheath assembly where the internalsheaths themselves become the supply lines and working channel for theendoscope and still run through the internal volume of the endoscope maybe advantageous. The external sheath part cannot only bend side to side,but also is flexible enough to support extension and retraction of theendoscope relative to the outer tube while maintaining a physicalbarrier to contamination.

Any of the endoscope sheath devices described herein may be used withnested endoscopes, either robotic or manual. For example an endoscopesheath device may be part of a system including an elongate outerendoscope and an inner endoscope arranged in a telescoping arrangement.The endoscope sheath device may be configured to fit over both the innerendoscope (that is fit into the outer endoscope) and the outerendoscope. Alternatively, as shown in FIGS. 15A-15D, the endoscopesheath device may be configured to fit over the inner endoscope and theninserted through the outer endoscope. FIG. 15A shows an example of aninner endoscope 1500 that, in this example, includes a first lumen 1501and a second lumen 1505. FIG. 15B shows an example of an endoscopesheath device 1535 that may be used with the first (inner) endoscope.The endoscope sheath device includes a cap 1525 to which an elongate,flexible and tubular external sheath 1502 is sealed. A pair of internalsheaths, e.g., a first internal sheath 1515 and a second internal sheath1517 extend within the length of the external sheath and are also sealedat their distal end regions to the cap so that the cap is open to allowpassage into the lumen of the first 1515 and second 1517 sheaths.

FIG. 15C shows the endoscope sheath device 1535 of FIG. 15B attachedover the inner endoscope of FIG. 15A. the cap may be attached (e.g.,latched, friction fit, snapped on, etc.) to the distal end region of theendoscope 1500. In FIG. 15C the endoscope may be inserted into a bodywithout risk of contamination, because the endoscope sheath device formsa complete barrier for both the outer surface and the inner (luminal)surfaces of the endoscope. The endoscope sheath device does not preventor limit (and may instead enhance) the operation of the lumen of theendoscope, while still maintaining a fluid-impermeable contaminationbarrier to prevent contamination. Thus, the inner endoscope may bereused after a procedure by removing the endoscope sheath device, asdescribed herein, without contaminating the endoscope. For example, theinternal sheaths may be sealed (by crimping, or otherwise) at theirproximal end and the external sheath may be inverted over itself bypulling it proximally partially or completely, preventing contaminationand trapping any contaminants within the inverted sleeve of the sheath.

The cap may include one or more transparent sections to allow use of thecamera and illumination built into the endoscope 1500. The endoscopesheath device's two internal sheaths may include lumen that may be usedto pass material through the endoscope by passing though the cap intothe lumen of the internal sheaths. A multi-lumen catheter may be usedfor one of or both of the internal sheaths, and may include sub-lumenfor irrigation, tip wash and/or insufflation lines, for example, whichmay be directed by the shape of the tip region, which may include adeflector, nozzle, etc. For example, the tip may include a tip washdeflector or nozzle that may direct fluid from the tip wash sub-lumen ofthe multi-lumen catheter forming one of the internal sheaths to directfluid to clean a window for the camera on the tip. As described herein,in some examples the tip may include illumination built into the capinstead of being on the endoscope.

FIG. 15D also illustrates the use of the endoscope with the appliedendoscope sheath device with a second (e.g. outer) endoscope. In FIG.15D the outer endoscope 1539 includes a lumen into which the innerendoscope covered by the endoscope sheath device may be inserted. Inthis example, the outer endoscope 1539 may be configured to act as anovertube, and may be single-use or limited use (e.g., disposable). Theendoscope 1500 may be a removable endoscope core that may be reusable.The endoscope 1500 may include one or more cameras, illumination, pullcables (e.g., for steering the distal end region), coil pipe assembly,bending section, etc. As mentioned, the endoscope may be inserted into afresh endoscope sheath device and secured in place by coupling the capto the distal end region of the endoscope and in some examples insertinginto the outer endoscope for performing a procedure.

In general, these methods and apparatuses may therefore replacecomponents having lower durability before each new procedure, includingreplacing the endoscope sheath device and any associated hydrophiliccoatings on the outside (e.g., configured to be positioned between theouter endoscope/overtube and the inner endoscope), while the innerendoscope can be reused multiple times. The inner endoscope maytherefore be hygienically draped by the endoscope sheath device, so thatit can be reused without requiring high level disinfection (HLD). Theinner endoscope may be fully shielded from any exposure to water andcontamination which facilitates simpler and more cost-effective designand construction. Further, the patient is therefore fully shielded fromthe second endoscope, potentially simplifying biocompatibility andcleaning requirements for the endoscope. The use of the endoscope sheathdevice may also extend the lifetime of the endoscope, including some ofthe costliest components of the endoscope, such as the camera andbending section components. This configuration may also permit theremoval and replacement of the inner endoscope during a procedure, whileleaving the outer endoscope/overtube in place. These methods may alsoaccommodate utilization of the exterior surface of the overtube foradding accessories, such as external working channels, as described inreference to FIGS. 16A-16B.

In general, any of the apparatuses described herein may include the useof external working channels over the endoscope sheath device and/orover an endoscope used in conjunction with the endoscope sheath device.FIG. 16A illustrates an example in which the apparatus shown in FIG. 15D(including an endoscope 1500, endoscope sheath device 1535 and outerovertube 1539) also includes external working channel 1545. Examples ofexternal working channels may be found, for example, in U.S. patentapplication Ser. No. 17/940,906, titled “EXTERNAL WORKING CHANNELS,” andfiled on Sep. 8, 2022, and U.S. patent application Ser. No. 18/000,062,titled “RIGIDIZING DEVICES,” and filed on May 26, 2021, each of which isherein incorporated by reference in its entirety.

The one or more external working channels 1545 may be expandable fromthe outside surface of the outer endoscope 1539 and may include aproximal insertion guide region 1547 for inserting one or more devicethrough the external working channel. FIG. 16B shows an example of asystem including an inner endoscope covered by an endoscope sheathdevice 1535 such as that described in FIGS. 15A-15D, that is slidablyarranged within the outer endoscope 1539. As mentioned, the outersurface of the endoscope sheath device may be coated with a hydrophiliccoating to assist in axial movement between the outer and innerendoscopes. The system shown in FIG. 16B also includes external workingchannels 1545 configured as a cover over the outer endoscope thatincludes a proximal insertion guide 1547. In FIG. 16B a tool 1549, 1549′is shown inserted through the insertion guide 1547 passing into theworking channel of the external working channel and extending distallyfrom the distal end of the outer endoscope. The proximal end of theinner endoscope 1558 is shown extending from the proximal end of theouter endoscope. In this example, the internal sheaths (not shown) mayextend proximally and may couple to, e.g., a source of aspiration,fluid, insufflation, etc. These working channels can co-exist with asheathing system, such that the underlying endoscope maintains itscleanliness, even as tools go through its working channels and tools gothrough the external working channels.

In any of these examples the external working channels may be mounted onthe overtube, as shown in FIG. 16B, e.g., using an overtube as describedin FIG. 4A. In this case, the working channels may be disposed of outafter each procedure, together with the overtube and the distal externalsheath.

In some examples the external working channels may be mounted on theexternal sheath of the endoscope sheath device. For example one or moreexternal working channels (including expandable working channels) may beincorporated into the external sheath, such as the full length externalsheath, which may fit over the outside of the endoscope or endoscopeassembly (e.g., FIG. >4C). In this configuration the working channelsmay be disposed of after each procedure together with the full lengthexternal sheath, but without requiring disposal of the overtube (whichis protected under the full length of the external sheath).

Any of the endoscope sheath devices described herein may be configuredas rigidizing endoscope sheaths. The endoscope sheath devices may berigidized in any appropriate manner, including, but not limited to,pressure rigidizing devices. For example, the endoscope sheath devicesdescribe herein may include a rigidizing external sheath configured toextend over an endoscope and may include a rigidizing layer comprisingmultiple strand lengths that cross over each other and a compressionlayer that is configured to apply force to the rigidizing layer whenpressure is applied in order to rigidize the rigidizing external sheathfrom a flexible configuration to a rigid configuration.

For example, FIGS. 17A-17D illustrate a system including an endoscope1700, having one or more lumens (e.g., in this example, a first lumen1701 and a second lumen 1705), and a rigidizing endoscope sheath device1735. The rigidizing endoscope sheath device includes a cap 1727 that isconfigured to attach to the distal end region of the endoscope 1700 andincludes one or more internal sheaths (in this example, a first internalsheath 1715 and a second internal sheath 1717) that are configured tofit within the endoscope 1700. The rigidizing endoscope sheath devicealso include a rigidizable external sheath 1702. The rigidizableexternal sheath 1702 is a tubular sheath that is sealed to the cap 1727.The external sheath 1702 may have an inner diameter that is slightlygreater than the outer diameter of the inner endoscope 1700.

The rigidizable external sheath 1702 may include a rigidizing layer orregion that engages with a compression layer (which may be or mayinclude a bladder) that applies force to the rigidizing layer torigidize the rigidizing layer or in some cases, to de-rigidize (e.g.,release from rigidization) the rigidizing layer. In some examples, theserigidizable external sheaths 1702 may include a rigidizing layer thatcould include a braid, knit, woven, chopped segments, randomlydistributed or randomly oriented filaments or strands, engagers, links,scales, plates, segments, particles, granules, crossing filaments, orother materials forming the rigidizing layer. For example, therigidizing layer may comprise multiple strand lengths or strand segmentsthat cross over each other (e.g., as part of a braid, knit, woven,etc.); the compression layer may apply force to drive the crossingstrand lengths or strand segments against each other. In some examplesthe rigidizing layer may be a braided layer, however any of theseapparatuses may instead or in addition include a general rigidizinglayer comprising crossing strand lengths or strand segments. Theexamples of rigidizing apparatuses described herein may use pressure(positive pressure) and/or negative pressure to selectively andcontrollable rigidize. In some examples the method described herein maybe used with any appropriate rigidizing apparatus.

FIG. 17C shows an example of the assembled inner catheter 1700 and therigidizing endoscope sheath device 1735. The inner rigidizing sheathesare inserted into the lumen of the endoscope, the cap is coupled to thedistal end of the endoscope, and the outer rigidizing endoscope sheath1702 extends over the outer surface of the endoscope.

Any of these systems may also optionally include a second, outer,endoscope 1739, as shown in FIG. 17D. Thus, these apparatuses may beused in a nested configuration. The outer endoscope may also berigidizing in some configurations.

As mentioned, the outer endoscope 1739 (e.g., overtube) may beone-time/disposable, and/or may be reusable (e.g., by cleaning or bysheathing). Similarly, the endoscope sheath device may be singleuse/disposable or may be reusable (e.g., by cleaning). The endoscope maybe reusable, and may include, e.g., a camera, illumination, pull cables,coil pipe assembly, bending section, etc. The inner endoscope may beinserted into a fresh endoscope sheath device and secured in place for aprocedure, and then unsecured and removed after a procedure.

In any of the apparatuses and method of using and making them describedherein, the internal sheath(s) may be configured to both preventcontamination and to pass one or more materials or objects. In general,the internal sheaths are typically tubular sheaths that are sealed sothat the distal outer edge is sealed circumferentially within an openingthrough the cap. Further the internal sheath(s) may be generally stifferthan external sheath and may sufficiently stiff so that they may bethreaded into the lumen of the catheter. Further, the internal sheathmay be sufficiently stiff so that it can allow unobstructed passage of amaterial when acting as an internal working channel (e.g., when theinternal sheath is acting as a working channel liner). In some cases,however, particularly when used with a steerable endoscope, such as theone shown in FIG. 18 , the internal working channel must be sufficientlyflexible to allow bending of the endoscope.

For example, in endoscopes such as the one shown in FIG. 18 , havedifferent bend radiuses at the different zones. The distal end region(“distal zone”) 1851 may be highly flexible, as shown, as the distal tip1543 of the endoscope, to which the cap of the endoscope sheath devicemay be coupled may be steered by bending a bending section 1541 of theendoscope. The endoscope may be steered or bent by any appropriatetechnique or structure, including tendons/pullwires, etc. The bending ofthe tip region may be particularly challenging for the internal sheath,as bending beyond a particular radius of curvature may result inpinching or collapse of the lumen of the internal sheath. Thus, theseapparatus may include tube reinforcement—particularly in the distal endregion corresponding to this distal zone 1851. However, it should beappreciated that other regions may also be reinforced, including theintermediate or middle zone 1853, which may extend to, or almost to, theproximal end of the catheter. The proximal zone 1835 may include theextension of the internal sheath 1817 beyond the catheter and/or theexternal sheath 1828 and may extend, for example, to a port adapter1868.

In some examples, the entire endoscope may be highly flexible, and theinternal sheaths may be highly flexible to match. To achieve both highflexibility and sufficient stiffness/radial strength to prevent collapseand allow easy insertion of the internal sheath(s), in any of theseapparatuses the internal sheath may be reinforced. Any appropriatereinforcement and extent of reinforcement may be used. For example, theinternal sheath may be reinformed by one or more coils that are woundhelically around and/or within the internal sheath to prevent localizedbuckling during tight curvature of bending (e.g., bending having aradius of curvature that is less than, e.g., 30 mm, less than 20 mm,less than 15 mm, less than 10 mm, less than 7.5 mm, less than 5 mm, lessthan 4 mm, less than 3 mm, less than 2 mm, etc.).

FIG. 19A illustrates an example of a first tubular internal sheath. Thisexample is a single-lumen internal sheath, which may be referred to as atube liner, as it lines the lumen of the endoscope. In FIG. 19A theinternal sheath 1650 includes a reinforced distal region 1651 and anun-reinforced middle region 1653. The reinforced distal region 1651 maybe reinforced by including an inner coil wound tube or by forming of amore flexible, yet collapse or buckling-resistant material (e.g.,polymeric material). In some examples, as shown in FIG. 19B the entirelength of the internal sheath 1650 is reinforced by a coil. Otherinternal sheaths may include more than one lumen and may be reinforcedas well. In some example, multi-lumen internal sheaths may not need tobe reinforced, as the division of the inner lumen into the multiplelumens may provide internal reinforcement.

The internal sheath in some examples is formed of an intermediatedurometer elastomeric by, e.g., extrusion. A slip additive may beincluded to help make the internal sheath slippery so that it slides ineasily, e.g., within the lumen of the endoscope, and relative to toolsthat pass within its inner diameter. In some examples the internalsheath may be formed as a composite structure. For example, a laminatedcoil wound tube may be used, with the coil pitch changing along thelength, and the coils may be formed from a flat wire. The flat wires maybe wound more densely in the distal zone to prevent buckling as thebending section is brought through a tight radius of curvature. Thematrix material forming the body of the internal sheath may be a lowdurometer elastomer (70A urethane) material. The inner surface of thetubular internal sheath may have a hydrophilic coating so that tools canslide easily. This can make the sliding far superior to that possiblewith standard PTFE tubing. For example, a reusable scope with thestandard PTFE tube may allow a tool to be inserted and perform twocomplete wraps (e.g., 2*360 degrees). With a hydrophilic coating, thiscan be increased to up to six wraps (e.g., 6*360 degrees). The drag inthis situation scales exponentially, particularly in long, bend/bendabletubes, thus this is a major reduction is drag, and an advantage of theendoscope sheath devices described herein. The resulting low drag mayenhance the tactile feel for the instrument. This is another example ofhow a sheathed system can outperform a reusable system.

Thus, the internal sheaths may be reinforced as described herein, and/ormay be formed of a material having sufficient properties (e.g., wallthickness, stiffness in bending, bucking in bending, buckling alonglength, etc.) to prevent pinching or collapse when manipulating theendoscope. In general, the interior sheath may be made of the samematerial as the external sheath, or they may be made of differentmaterials. Examples of appropriate materials for the internal sheath mayinclude, but are not limited to: polytetrafluoroethylene (PTFE),fluorinated ethylene propylene (FEP), perfluoroalkoxy (PFA),high-density polyethylene (HPDP), low-density polyethylene (LDPE),polyether block amide (e.g., Pebax™) expanded Polytetrafluoroethylene(EPTFE, e.g., Fluroflex™), Urethane, etc. These materials may beextruded and may be combined with other materials, such as, for example,with a heat set metal coil, coil wound with round wire, flat wire, etc.Examples of materials for the external sheath may include (but are notlimited to): LDPE, polyolefin plastomers, nylon, composite materials(for example, thin films laminated with a urethane, including highperformance fibers inter-dispersed (for example, Dyneema, Technora,carbon fiber, fiberglass, etc.), silicone, and urethane. These may bemanufactured by multiple methods, including, but not limited to:extrusion, blow molding (including bellows designs), lamination, heatsealing.

In general, the endoscope sheath devices described herein may include atip that includes features that permit the endoscope sheath device toeasily and effectively secure to the distal end region of the endoscope,the permit the external sheath and the internal sheath(s) to form a sealwith the cap, and that may include integrated features to assist in thefunctioning of the endoscope to which the endoscope sheath device isattached. For example, an endoscope sheath device may include a tiphaving any of the feature shown in FIG. 20A-20D, 21C, 22A-22C, 23A-23B,24A-24B, 25, 26A-26B, 27A-27C, 28A-28D, 29A-29B, 30A-30B, 31A-31B,32A-32B, 33A-33B, 34A-34B36A-36B or 38.

For example, FIGS. 20A-20D illustrate one example of a cap includingfeatures that may be included in any of the endoscope sheath devicesdescribed herein. The cap shown includes a distal face that may be allor partially transparent, and may include a transparent camera region2026 through which a camera on the endoscope may image. As shown inFIGS. 36A-36B, in some examples the cap may include integrated lenses orcameras. In some examples the cap may further include a transparentlight-passing region 2024 allowing transmission of light through the capfrom the endoscope. The cap 2018 may also include one or more opticalcomponents (e.g. diffuser, lens, etc.) for modifying the illuminationlight. In some examples the cap may alternatively or additionallyinclude one or more light sources, e.g., LEDs. The cap may include oneor more openings corresponding to the internal sheath regions, includingthe opening into the lumen of the first internal sheath 2023 and/or thesecond internal sheath 2022. Any of these apparatuses may also includeone or more flow directors or displacers 2020 that may direct (orre-direct) flow of one or more agents (e.g., wash solution, air, etc.)from the proximal end of the device. For example, the cap may include awash nozzle or wash director outlet 2021 which may be part of the fluiddisplacer 2020 on the cap.

For example, FIG. 20A shows an end view of the cap in this example. FIG.20A shows an end-on view of the cap. FIG. 20B shows a side perspectiveview, including a cylindrical mating region 2033 that may initially beoval, as shown in FIG. 20D. The oval-shaped mating region may, in anunconstrained configuration, have an oval cross-section, transverse tothe long axis of the device. The side view of FIG. 20B also shows thatthe cap may include one or more regions for coupling with all or aportion of the cylindrical external sheath; in FIGS. 20B and 20C, thecap includes a recessed mating region 2049 into which the externalsheath may be sealed, for example, with an elastic member (elasticretaining ring, not shown) and/or adhesive and/or a heat seal.

As shown in FIG. 20D the cap 2018 may include an oversized rim 2036extending around the cylindrical mating surface 2033. FIG. 20D shows theinside of the cap region. Showing the recessed or cut-out inlets 2022,2023 for receiving and sealingly bonding to the internal sheaths. Theinside of the cap also includes a recessed region 2039 for receiving theoptics from the endoscope (e.g., camera, lens, light director, etc.).

The end cap shown in FIGS. 20B-20D also includes a latch region 2038extending through the mating surface that is configured to mate with adistal end of the endoscope, by compressing the mating surface from anoval resting cross-sectional configuration into a circular matingcross-sectional configuration. The latch 2038 may be formed in thisexample as an opening into which a protruding latching member, e.g., onthe distal end region of the endoscope, may engage. Alternatively insome examples the protruding latching member may be on the cap and mayengage with a latch opening on the distal end of the endoscope.

Any of these caps may also include one or more stress relief regions2039, including stress-relief cutout regions, that may make it easierand more reliable to compress the cylindrical mating region 2033 (e.g.,wall).

For example, FIGS. 21A and 21B show examples of the distal end of anendoscope including a camera 2106, light 2104, and first 2108 and second2109 lumen through the endoscope. The endoscope in this example alsoincludes an outer diameter surface 2174 on which the mating latchcomponent (e.g., a ramped latch protrusion 2112, 2112′ in FIG. 21B) ispresent. FIG. 21C shows a front view of the endoscope sheath device ofFIGS. 20A-20D attached to a distal end of an endoscope. The cap 2118 inthis example may be applied by first applying pressure (e.g., squeezingthe cap) to circularize the oval mating wall then sliding it over thedistal end and engaging the latches 2112 on upper and lower regions.This is illustrated in FIGS. 26A-26B. In this example, the cap 2613includes a cylindrical mating surface 2033 that is formed in an(at-rest) oval cross-sectional shape. Transitioning from the ovalcross-sectional shape to a more round shape matching the perimeter ofthe catheter may allow the endoscope sheath device to be slid onto themore circular endoscope distal end and mate with the latchingcomponents. Once pressure is released, the cap may return to a slightlymore oval configuration, applying force to the hold cap onto the distalend region.

As in shown in FIG. 21C the cap may include one or more structures, suchas a fluid displacer 2120 that may allow the cap to direct the flow ofmaterial (e.g., wash) from the lumen of the internal sheath. In FIG. 21Cthe internal sheath in this lumen of the catheter is a multi-lumencatheter partitioned into three regions: insufflation, wash andirrigation.

As mentioned, any of these caps and therefor any of the endoscope sheathdevices described herein may include one or more light sourcesintegrated into the cap. For example, FIGS. 22A-22C illustrate oneexample of an endoscope sheath device that includes a cap 2218 with anintegrated set of LEDs in the lens (rather than, or in addition to,transmitting light from the endoscope). In FIG. 22A the endoscope sheathdevice includes an external sheath 2228 sealed to the perimeter of thecap 2218, e.g., within a channel that secures the external sheath by agasket 2241. A pair of internal sheaths 2210 extends from the cap (e.g.through the cap and sealed around the inner surface of the openingsthrough the cap) and into the lumen of the endoscope 2222. The cap mayinclude other features, including a fluid displacer 2220.

The cap 2218 shown in FIGS. 22A-22C also includes a plurality of LEDlights 2243 that are arranged at least partially around the perimeter ofthe cap. The LEDs are attached to a substrate 2244 that is held orformed within the cap. The LEDs may be powered by including one or moreelectrical contracts on the inside of the cap that may make contact withcorresponding contacts on the end of the endoscope. For example, FIG.22C shows a region of multiple electrical contacts 2239 on the endoscopethat make electrical connection with one or more pads, pins and/orcontacts on the cap once the cap is applied. In this example, the ovalmating wall may include one or more of the electrical contacts needed topower the LEDs. These contacts may also be configured to be on theregions of the walls near the minor axis of the cross-section throughthe oval (e.g., elliptical) mating wall; this same region may includethe latch 2238 (e.g., latch opening and/or latch projection).

FIGS. 23A-23B illustrate another example of a cap portion of anendoscope sheath device including a plurality of LEDs 2343, similar tothe arrangement of FIGS. 22A-22C. In FIGS. 23A-23B the cap is configuredas a disposable cap with a transparent window. The endoscope sheathdevice may be placed over an endoscope in use. However if the endoscopehas a camera and illumination ports, this may cause reflected light fromthe illumination ports to create reflection artifacts in the cameraimage. To avoid this problem, in some examples the cap may includeillumination ports, for example, including LEDs as described above. Forexample, the LEDs can be placed along the outside edge of the disposablecap. Arranging illumination on the disposable cap would also free upvaluable space on the face of the endoscope to support other features,or to decrease the diameter of the endoscope. One embodiment may includeone to three white light LEDs. In the case of multiple LEDs, thedifferent LEDs may be arranged at equidistant intervals around theoutside perimeter of the cap (facing forward), but could be arranged inother patterns.

Some imaging arrangements may use illumination other than white light.For example, green, blue, and ultraviolet (UV) light may be used tohighlight surface features of the tissue. Infrared illumination may beused with fluorescence, with or without other bands of illumination.Alternate illumination schemes may be “steady state,” with the visionsystem switched into an alternate imaging mode and staying there untilthe user switches back to white light illumination. Alternatively, thevision system may change illumination patterns at frame rates,alternatively illuminating a frame with white light, then withalternative illumination, or using other temporally varying patterns.Image interpolation may be used by the systems described herein todisplay an alternative image overlaid with a white light image. An arrayof LED's, lasers, or other illumination devices on the disposable capcould enable these alternative imaging approaches. For example, a capwith three LEDs each of red, green, blue, and UV light could allow thevision system to image both in white light, and in an alternative modeto highlight details on the surface of the tissue. In the example shownin FIG. 25 , these LEDs 2543 are arranged in three clusters spaced 120degrees apart on the face of the cap 2513, with each cluster containinga red, green, blue, and UV LED closely spaced. Other configurations maybe used.

In some examples wires (e.g., wire leads) may be used to power the LEDs.These wires may be routed through the endoscope, with electricalcontacts between the cap and endoscope body as mentioned above.Alternatively, wire leads could be integrated into the external sheaththat is attached to the cap, for example, running in a spiral around theexternal sheath in order to prevent limiting movement of the endoscope.Alternatively, in some examples the wires may run down or through theinternal sheath (or more than one internal sheath). For example, thewires may be encapsulated thin wires.

FIGS. 24A and 24B illustrate examples of multi-lumen extrusions withembedded wires (in this example, the wires are enclosed in twin 0.013″lumens). In FIG. 24A the embedded wires 2481 may be coupled to one ormore LEDs (not shown) and the frame may be configured to fit over thedistal end of the device as described above, including cut-our regionsto allow imaging and/passage of light.

As mentioned above, in some examples the caps may be applied and/orremoved from the endoscope by applying compression across the large axisof the oval, cylindrical mating wall. For example, FIGS. 27A-27Cillustrate removal of a cap (the external sheath has been removed toshow the application of a compression force to remove the device fromthe tip). As shown, the cap is disengaged by squeezing the cap to deformthe mating wall to allow the latch members to uncouple (FIG. 27B) sothat the cap can be pulled up and off of the endoscope, leaving theendoscope clean and ready for another use.

FIGS. 28A-28D and 29A-29B schematically illustrate this method. Forexample, in FIG. 28A the first set for attaching the endoscope sheathdevice to the endoscope 2800. The internal sheath(s) 2815, 2817 of theendoscope sheath device may be inserted into the lumen of the endoscopeand the endoscope sheath device may be slid 2883 proximally until thecap 2813 is near the distal end region of the endoscope, as shown inFIG. 28B. Once the cap 2813 is in position, the user may use theirfingers to compress the cap and deform the shape of the cylindricalmating wall 2884 so that it may fit over the distal end region of theendoscope, as shown in FIG. 28C; the pressure applied to the large axisof the cylinder may circularize this otherwise oval cross-sectional areauntil it can fit over the endoscope, which has a round cross-sectionalarea, shown in FIG. 28D. The position and extent of the stress-reliefwindow 2893, cut through the cylindrical mating way on the oppositesides of the minor axis of the transverse section through thecylindrical wall, may make changing the cross-sectional shape of thecylindrical mating way from the oval to a more circular shape easier.The application of this compressive force 2985 may also help engaging ordisengaging the latch 2992. FIGS. 30A-30B illustrate the application ofcompressive force 2985 to elastically deform the cylindrical wall havingan oval cross-section, as described above.

As mentioned above, any of the caps for the endoscope sheath device mayinclude one or more features for directing the flow of material into orout of the endoscope. For example, the endoscope sheath device includinga cap such as the one shown in FIGS. 31A and 31B may include integratedor attached features to direct the flow of fluid wash, fluid irrigation,and/or insufflation. In this example the endoscope sheath deviceincludes a multi-lumen catheter 3115 forming one of two tubular internalsheaths. A second single-lumen sheath 3117 is also included. Themulti-lumen sheath 3115 in this example is divided up into threesub-lumen that may be accessed at the proximal end of the device by aport adapter to apply each of: insufflation 3142, wash fluid 3143 andirrigation fluid 3144. This is illustrated in FIGS. 35A-35D, showing theoperation of an example of a port adapter 3569. In this example themulti-lumen internal sheath 3516 is inserted fully into the port adapteruntil a latch engages with the distal end of the port adapter,indicating that the lateral openings into the different lumen arrangedat different longitudinal positions along the length of the internalsheath are aligned with the appropriate sealing regions of thereceptacle manifold of the port adapter. For example, in FIG. 35A theirrigation port 3576 into the first lumen is accessed from the positionso that irrigation fluid may be applied through the port adapter inputfor irrigation fluid 3571. The wash fluid port 3577 into the secondlumen is accessed from the middle position so that wash fluid may beapplied through the port adapter input for wash fluid 3573. Theinsufflation port 3579 into the third lumen is accessed from the moreproximal position so that insufflation may be applied through the portadapter input for insufflation 3574. FIGS. 35B-35C show end views ofthese different ports.

Returning now to FIGS. 31A-31B, the insufflation 3142 may be directedout of the multi-lumen catheter forming the internal sheath 3115 by thedeflector 3120 so that the insufflation 3142, 3242 is directed acrossthe camera region. This is shown in greater detail in FIGS. 33A-33B. Theflattened triangular component is representative of the general locationof the insufflation. Similarly, the wash fluid 3143, 3243 is directedout of the multi-channel lumen of the internal sheath by a deflector3120 on the cap 3113 that may direct the wash fluid across the outersurface of cap 3213 to clear debris that may otherwise occlude thecamera. This is shown in greater detail in FIGS. 32A-32B. The bentcylindrical shape shown to represent the wash fluid 3243 isrepresentative of the general direction of flow of the wash fluid.Irrigation fluid 3144, 3442 may be directed from out of the multi-lumencatheter forming the internal sheath as shown by the representation ofirrigation in both FIGS. 31A-31B and 34A-34B.

As discussed above, the cap may also include one or more opticalcomponents integrated into (including formed integrally in) the cap. Forexample, any of these endoscopic sheath devices may include a cap havingan integrated lens or lenses for the camera of the endoscope, as shownin FIGS. 36A-36B. In this example a domed lens 3652 is formed as part ofthe cap 3600, which may include other components such as a fluiddisplacer 3620. When the cap is attached to the distal end region of anendoscope as shown in FIG. 36B by cross-section, the camera of theendoscope 3688 is in direct communication with the lens 3652 formed onthe cap. The endoscope sheath device 3600 of FIGS. 36A-36B also includesa second internal tubular sheath 3617 that is configured as an internalworking channel and is lined by the second internal tubular sheath 3617.

Any of the apparatuses described herein may include one or moreaccessory elements that are configured to be used with the endoscopesheath device, such as scope caps and the like. These accessories may beadded or coupled to the endoscope sheath device after or before it hasbeen applied to an endoscope, or they may be integrated into theendoscope sheath device, e.g., as part of the cap. For example, FIGS.37A-37C illustrate an example of a removable scope cap 3700 that includea retention feature 3708 (in this example, configured as a bayonet typeattachment). In FIG. 37A the removable scope cap 3700 is separate fromthe endoscope sheath device (e.g., the cap 3713 of the endoscope sheathdevice) and in FIG. 37B the removable scope cap 3700 is coupled to thecap of the endoscope sheath device. FIG. 37C show a side sectional viewof FIG. 37B.

In general, the methods described herein may include attaching, removingand/or swapping out of different scope caps depending as necessary tothe user. In some examples the endoscope sheath device may be configuredto integrate one or more of these features, such as a scope capextending from the distal end. FIG. 38 illustrates an example of a cap3813 in which the scope cap portion 3800 is integrally formed with therest of the cap.

Also described herein are endoscopes that may be modified to more easilyoperate with the endoscope sheath devices described herein. For example,FIG. 39A illustrates an example of a prior art endoscope including anelongate body 3928 having a distal end region 3918 and a plurality ofinternal lumen 3957. In this example the lumen are coupled to suction3958 and air/water 3959. The device may also include valves, such assuction valves 3953 and air/water valves 3951 that may regulate the flowof suction, air and/or water within the lumen. The handle region 3966may be coupled to the elongate body 3928 and to a cord that may connectto the source of suction and/or air, e.g., via a suction connector 3960or air pipe 3962.

Any of the apparatuses described herein may include an endoscope that isadapted for use with an endoscope sheath device; these systems mayinclude endoscope devices in which the valves controlling the flow ofmaterial (e.g., vacuum, water, air, etc.) in the lumen of the endoscopemay be separate from the separate and/or may be disposable. For example,a catheter adapted for use with an endoscope sheath device may include ahandle region that is configured to pass the internal sheath(s). In someexamples the endoscope has an elongate member with a lumen extendingfrom a handle. The system may also include an endoscope sheath devicethat includes the external sheath, an internal sheath comprising one ormore lumens and a cap as described above. The system may also include amanifold block that is removably coupled to the handle of the endoscope,wherein the manifold block comprises one or more valves in fluidcommunication with the lumen of the endoscope. The internal sheath maybe configured to engage with the manifold block so that the one or morevalves control passage of fluid through the one or more lumens of theinternal sheath.

For example, FIG. 39B schematically illustrates an endoscope asdescribed herein. In this example the endoscope includes an elongateshaft (endoscope shaft) having two internal lumen. The first lumen isfor accepting a working channel and/or suction channel. The second lumenis for accepting a multi-lumen channel that may couple to insufflation,wash fluid and irrigation fluid. In FIG. 39B the elongate shaft iscoupled to a handle region. The handle region may also include adisposable manifold block that may include a plurality of valves and/orcontrols for engaging with the internal lumen and/or for controlling theflow within the lumen. For example, the disposable manifold block mayinclude manual button valves and/or check valves that prevent flow inthe reverse direction, but permit flow of fluid from the handle to thedistal end of the shaft. The apparatus may also include asealing/crimping region (e.g., a heat sealing access point) to allow theinternal shafts to be sealed when use is complete. Finally, theapparatus may also include a line (“umbilical” line) and connectors forcoupling to the sources of irrigation (water), wash, insufflation(air/CO2) and/or suction.

In general, the device shown in FIG. 39B is configured for use with anendoscope sheath device so that the external sheath may cover theoutside of the distal end and shaft (and in some examples, the handle,and optionally the umbilical) and the internal sheaths may extend withinthe lumen and through the manifold block to couple with the connectors.Thus the manifold block may be adapted to receive the internal sheathsand the valves and controls may operate on the internal sheaths.

Any of the apparatuses and methods described herein may be configured toapply positive or negative pressure between the external sheath of theendoscope sheath device and the outer surface of the endoscope. Thus,any of these apparatus may be configured to apply negative pressure(e.g., vacuum) to adhere the external sheath to the outside of theendoscope, which may make it easier to hold and use (e.g., applytorque). The use of pressure, including negative pressure, may alsoalert the user to any leaks or ruptures in the sheath. Alternatively,any of these methods and apparatuses may use positive pressure toinflate the external sheath, which may help with navigation, deploymentand/or leakage detection.

In any of these apparatuses and methods the endoscope sheath device maybe configured to allow pressurization of the external sheath by forminga seal at the proximal end region of the external sheath, e.g., on theendoscope sheath and/or handle. The distal end region, including thecap, may also form a seal, or in some examples may not seal, but may besealed around the more proximal ends of the internal sheath(s).

FIGS. 40A-40C illustrate a first example of a system including anendoscope sheath device that is configured to pressurize the externalsheath of the endoscope sheath device. FIG. 40A schematicallyillustrates an example of an endoscope 4000 that include an elongateshaft 4001 and a handle region 4003. In this example the endoscopehandle may include a pressure line 4007 (e.g., for positive or negativepressure) that may be used to apply pressure between the endoscope andthe external sheath. In some examples the pressure line is coupled tothe endoscope sheath device, e.g. at the sheath proximal collar. Thepressure line may be integrated into either the endoscope or theendoscope sheath device or it may be a separate and individuallypositioned line.

FIG. 40B schematically illustrates an endoscope sheath device thatincludes a pressurized external sheath 4002, and a pair of internalsheaths, as well as a cap 4027 sealed to the external sheath andinternal sheath. The endoscope sheath device also includes a proximalcollar 4044 that is configured to maintain a seal between the endoscopeand the proximal end of the external sheath.

FIG. 40C shows the endoscope of FIG. 40A with the endoscope sheathdevice of FIG. 40B applied, creating a sealed zone or region between theexternal sheath and the endoscope that may be pressurized, e.g., byapplying vacuum to collapse the sheath onto the endoscope or applyingpositive pressure, e.g. to expand or inflate the external sheath. Thecollar 4044 may be activated to form an airtight seal 4043 (e.g.,proximal sealing collar). In FIG. 40B the external sheath of theendoscope sheath device has a substantially uniform diameter along theproximal-to-distal length. In some cases it may be beneficial to haveregions of different radial diameter along the length and/or regions ofdifferent elasticity so that the different regions may be inflateddifferently.

The proximal sealing collar 4043 may be configured to seal the outersheath to the outside of the endoscope. Any of these apparatuses mayalso or alternatively include a seal (e.g., an O-ring or other annularseal) between the inner sheath and the inner lumen of the endoscope.Thus, in any of these examples pressure may be applied between either orboth the outer sheath and the endoscope and/or the inner sheath and thelumen of the endoscope (or multiple inner sheaths and lumens of theendoscope). In some cases the cap may include one or more openings orchannels to allow passage of pressurized fluid (e.g., air, saline,water, etc.) from between the outer sheath and the outer surface of theendoscope and between the inner sheath(s) and the lumen(s) of theendoscope. Thus the patency of the entire sheath (both outer sheath andone or more inner sheaths) may be concurrently examined. Alternatively,these apparatuses and methods may determine a leak in outer sheathalone.

Any of these apparatuses may include an indicator configured toindicate, based on a decay of pressure from between the external sheathand the endoscope, if the sheath device has a leak indicating potentialcontamination. The indicator may be analog, digital or both. Theindicator may include indicator circuitry having logic to determine if apressure leak above a threshold (pressure leak threshold) corresponds toa tear, rip or disruption of the outer and/or inner sheath(s) andtherefore a likelihood of contamination. The indicator may be coupled tothe sheath and/or to the endoscope. In some examples the indicator iscoupled to an inlet for pressurizing the space between the outer and/orinner sheaths and the endoscope. The inlet may be part of the sheathdevice (e.g., part of the proximal collar) and/or part of the endoscopeand/or part of a pressure source coupled to either the endoscope and/orthe sheath device. The indicator may include a speaker, display, etc.

For example, FIGS. 41A-41C illustrate examples of endoscope sheathdevices having different configurations of the external sheath. Thesedifferent configurations may be particularly helpful during inflation.The flexible external sheath portion of the endoscope sheath device mayhave a constant cross-section as shown in FIG. 40B. Alternatively, thecross-section may be nominally larger than the shaft, such that it canslide on easily with a small annular gap. Any of these external sheathsmay be relatively elastic, such that they may be vacuumed out to expandit (for example, by sealing at either end into a rigid tube, with theannular space between them a space that is then vacuumed). Once inplace, e.g., with the sheath fully positioned over shaft, the vacuumcould be released so that the sheath elastically recoils and then liessnugly against the shaft. This is illustrated in FIG. 41A, showing theexternal sheath having a constant diameter but held within an outer,e.g., rigid, tube. The external sheath is then vacuumed out into thisspace to expand it during install. In FIG. 41A the external sheath 4027has a constant width. Once in place, vacuum may be released, and theexternal sheath may elastically return to the released size to snuglyconform to shaft.

In some examples the external sheath may be substantially larger (e.g.,greater than 1.5× diameter, 2× diameter, 2.5× diameter, 3× diameter,3.5× diameter, 4× diameter, 5× diameter, etc.) than the shaft. Thisconfiguration may be advantageous once inflated by positive pressure, asit may help position, stabilize, anchor, and/or guide the device withinthe anatomy, particularly tortious anatomy.

In some examples (see, e.g., FIG. 41B) the external sheath may have atapered or a stepped cross section (see, e.g., FIG. 41C), larger at theproximal end. This sort of profile could assist with removal—it iseverted back on itself during removal, thereby ‘capturing’ biologicaldebris on the outside, making its disposal cleaner and easier. This mayalso facilitate installation and hygienic removal of the replaceablesheath. In some examples the endoscope sheath device may be configuredto seal at either end, such that it could then be vacuumed down againstthe elongate shaft.

In any of these methods and apparatuses the sheath may be installed overthe device, either as a manual device (scope or catheter) or as arobotic device (a tele-operated device).

During use, the external sheath may be snug, or it may be loose relativeto the endoscope shaft. The external sheath may be a sealed structureonce it is co-joined with other structures—including the shaft orinstall tools. At the proximal end, it may have a port that allowsaccess to that (annular) space. Through that space positive or negativepressure may be applied. As negative pressure is applied, the sheathwould be suctioned down to the underlying structure, such that it isvacuum co-joined with that structure. If the device is manuallyoperated, that enables the hand to better grip that surface, and for thesheath and the underlying shaft to move as one. Should the sheath not bevacuumed, such movement would be difficult, as the sheath would bemoving and shearing relative to the elongate shaft during attempts atmovement.

During installation, the sheath may be co-joined with an installationtool. Once it is co-joined, the annular space between them (theinstallation tool and the sheath) could be vacuumed, thereby causing thesheath to elastically expand. This would give it a larger innerdiameter, such that it could more easily expand over the shaft. Once ithas been loaded over the shaft, vacuum would be released and it wouldelastically reduce its diameter, such that it would be snug to theshaft.

In any of these methods and apparatuses, the sheath can be inflated withpositive pressure. When inflated, the sheath can contact the anatomy.For example, it can contact the inside of the lungs, the inside of theGI tract, etc. This may similarly function in other anatomies, includingbut not limited to gynecology, abdominal, orthopedic, vascular,neurovascular, and peripheral vascular. This application of positivepressure and its interaction with anatomy creates co-joined stability.This contact could present locally (i.e., as a single balloon), inmultiple locations (serial balloons), or over a long length (constantdiameter interaction, tapered geometry interaction, etc.).

The endoscope sheath device may be packaged in multiple configurations,including straight and coiled. These packaging configurations may becreated to decrease installation difficulty and time, and to reducepackaging, shipping, and sterilization costs. The endoscope sheathdevice may be configured to easy removal. For example, after use, theoutside surface of the device may be contaminated with feces, blood, andother bodily fluids. It may be difficult or cumbersome to handle. Thedevice may be configured such that it everts (i.e., rolls back onitself). By doing so, it thereby reduces the effective sheath length(everting doubles the wall, and thereby reduces the length by half).Everting also serves to have the exterior (contaminated) surface facinginwards, with the clean surface facing outward, such that it can beremovably handled in a more sanitary manner. For example, FIG. 44illustrates an everting sheath 4407 that is configured for easy removal.

In some examples it may be important to have the sheath electronicallyregister with the base device. This registration may transmitinformation, including about the device type, its operation, itsmanufacture, its authentication, its sterility, or the legality of itsintegrative use. A reader and/or transmitter (e.g., RFID) may beinstalled, for example, on the base. As the sheath proximal collar is inproximity, it may register or transmit information.

FIG. 42 illustrates an example of an external sheath 4227 being vacuumedonto the endoscope 4201. The sheath is sealed onto the endoscope shaftdue to an applied vacuum 4007 between the sheath and shaft. Theapplication of negative pressure (vacuum) pulls the external sheathinwards, against the endoscope. Applying a vacuum (e.g., between theshaft and the sheath) shrink-fits the flexible sheath onto the endoscopeflexible shaft. For a manual endoscope, this may improve the ability tomanually grasp and control the shaft by preventing slippage between theexternal sheath and the shaft, both longitudinally and torsionally. Thevacuum can be released to remove the sheath. Further, measuring forvacuum leaks can be used to determine if there is a leak in the sheath.

FIGS. 43A-43B illustrate the application of positive pressure. FIG. 43Ashows an example of an endoscope sheath device having a single distal“balloon” shape when inflating the external sheath 4227′. FIG. 43B showsan example of an endoscope sheath device with multiple annular balloonshapes. In these examples, when positive pressure is applied the sheath4227″ can inflate similar to a balloon. Pressurized gas or fluid may bepumped into the space between the sheath 4227′, 4227″ and the endoscopeshaft 4201. Various expanded balloon profiles can be utilized which caninclude, but are not limited to: single distal balloon shape, multipleannular ring balloon shapes, helical balloon shape, constant diameteretc. The expanded balloon can help stabilize and center the device inthe anatomical lumen.

Also described herein are flexible devices (endoscopes, catheters) thatcan get deep into anatomy (e.g. the lungs periphery, the GI tract).However, when they are small and flexible enough to do, kinematic issuesbecome apparent, including looping, prolapse, ‘tram-tracking’, andbuckling. Although there are many strategies to overcome these issues,including by reducing clinical expectations, changing patient position,pushing on localized anatomy, and attempts to solve this by usingsteering, sheaths, and overtubes, in many instances (for example, in thelungs) the overtube may become too large such that it cannot progressforward. This sort of buckling, as depicted in the lungs, is shown inthe FIG. 45 , showing buckling of the endoscope while trying to get tothe lung periphery. The use of a sheath, coupled with the use ofpositive pressure to inflate the sheath, may help to solve this problem.As shown in FIGS. 45A-46B, the apparatus may have an external sheath4607 that goes over the device and overtube 4674. The accordion, zig zagregion on the sheath indicates a stretcher material.

At the point where the overtube 4674 can no longer progress any fartherwithout pulling the scope back, since the anatomy is too tight, thesheath may be pressurized (by the application of positive pressure) tothe region between the sheath and the endoscope/overtube. Inflating thesheath potentially does two things: it stabilizes the outer diameter ofthe device through local anatomical contact, and it turns the deviceinto a pneumatic or hydraulic cylinder, thereby facilitation forwardmovement of the tip through the application of the positive pressure.This may minimize the buckling risk of pushing a very flexible scopeforward from the proximal end. This is shown in FIGS. 46A and 46B.

The overtube 4674 (e.g., outer endoscope of a nested pair of scopes) maybe moved forward in tight anatomy without dragging the device backwardsby further inflating the sheath but hold the device stationary. This maycause the sheath 4607′ to balloon out, and can be used as an anchoragainst anatomy and then the device becomes similar to a more stableguidewire that can guide the overtube forward without getting pulledback itself. This is shown in FIG. 47 . Once the clinician has reachedtheir anatomical target, they may choose to ‘lock’ the tip of the devicein place, which may be similar to the technique of inflating a distalballoon. Alternatively, they could choose to inflate their sheath 4807over a much longer length to get traction over more anatomy, asillustrated in FIG. 48 . Positive pressure could be applied with a gas,or with a liquid (e.g., saline).

These apparatuses may be used with a side mounted ultrasound, as shownin FIG. 49 . Thus, the saline-inflated external sheath may act as asaline-filled balloon when combined with ultrasound, which may help tolocalize targets that cannot be visually seen. FIG. 49 illustrates aside-mounted ultrasound device including an ultrasound transducer 4906within an inflated external sheath 4907.

Installing Handle

Any of the endoscope sheath apparatuses (e.g., endoscope sheath devices)described herein may include an installing handle for applying and/orremoving the apparatus from an endoscope. For example, FIG. 50A shows anendoscope sheath apparatus including a cap 5027 that is configured tosecurely couple to an endoscope, an external sheath 5002, 5002′, a pairof internal sheaths 5015, 5017 and an installing handle 5081.

In general an installing handle is configured to hold or gather theflexible/compressible external sheath in a compact and easy tomanipulate form, while permitting easy placement of the one or moreinner sheath members. The installing handle may include a body, which inFIGS. 50A-50C is cylindrical, but any appropriate shape may be used, andan inner chamber into which the external sheath 5002′ may be gathered.The external sheath may be gathered by pleating, folding (e.g.,accordion folding, bellows folding, etc.), scrunching, etc. The externalsheath may be gathered so that there remains a passage through thegathered external sheath that the endoscope may be inserted through asthe inner sheath(s) 5015, 5017 are inserted into the lumen(s) of theendoscope as will be illustrated in FIGS. 51A-51D.

The installing handle 5081 may include an outer gripping region 5087,which may be configured to fit into a user's hand. The installing handlemay also include a distal-facing conical surface (or distal funnel) 5088that may be particularly useful when removing the external sheath, asdescribed in FIGS. 54A-54C. Any of the installing handles describedherein may be configured to couple or attach to the endoscope, such asto the proximal end of an endoscope. Thus, in some examples theinstalling handle may include a coupler at the distal end of theinstalling handle that is configured to couple to a matching attachmenton the endoscope. In FIGS. 50A-50C the coupler 5085 is configured as aBNC-type coupler that may engage a pin on the endoscope, but anyappropriate coupler (and complementary attachment on the endoscope) maybe used.

In the installing handle 5081 example shown the installing handleincludes a window or opening 5083 that may open into the internalchamber holding a portion of the external sheath 5002′.

FIGS. 51A-51D illustrate the application of the endoscope sheathapparatus shown in FIGS. 50A-50C onto an endoscope assembly 5100. Theendoscope assembly shown in this example include a nested pair ofendoscopes including an inner endoscope 5103 that is nested within, andmay be slidably coupled to, the outer endoscope 5201 (e.g., overtube).In this example the inner sheaths 5015, 5017 that extend proximally fromthe endoscope sheath apparatus are first inserted into a pair of lumensin the endoscope from the distal end of the endoscope, as illustrated inFIG. 51B. The distal end of the endoscope is inserted through theproximal end of the installing handle 5081, into the lumen of thetubular external sheath that is held gathered in the chamber of theinstalling handle, until, as shown in FIG. 51C, the distal end of theendoscope (e.g., inner endoscope 5103) is engaged with the cap 5027 ofthe endoscope sheath assembly. The user may then pull 5189 theinstalling handle 5081 proximally so that the external sheath 5002 ispulled over the endoscope, as shown in FIG. 51D. Drawing the installinghandle proximally relative to the endoscope causes the external sheathto be dispensed distally out of the installing handle. In FIG. 51D theexternal sheath is shown matching the outer diameter of the differentregions of the inner endoscope 5103 that is nested onto the outerendoscope 5101 (e.g., as it may when negative pressure is appliedbetween the external sheath and the endoscope(s), as described above. Inany of these apparatuses and methods the external sheath may have auniform diameter that may accommodate the outer diameter of both theinner and outer endoscopes. The same apparatus and techniquesillustrated here may be used with a single (e.g., non-nested) endoscope.

In FIG. 51D the installing handle 5081 may be coupled to the outerendoscope 5101 by engaging the coupler 5085 with a complementaryattachment on the endoscope, as illustrated in greater detail in FIGS.52A-52B. As shown in this example the proximal end of the outerendoscope 5287 includes an attachment 5286 (shown in this example a pin)that may be engaged with the coupler 5085 (shown in this example as achannel, e.g., having a BNC-type configuration) of the installinghandle. FIG. 52B shows the installing handle engaged with the pin of theendoscope. Any appropriate coupler may be used (e.g., magnetic,mechanical, etc.).

The endoscope sheath apparatuses described herein may generally bepackaged in a primed state, ready for applying over an endoscopy orendoscope assembly. This may include packaging with the installinghandle. The primed state may include inverting and/or compressing (e.g.,pleating, folding, scrunching, etc.) the external sheath and/or loadingit into the installing handle. For example FIG. 53 shows an examples ofan endoscope sheath apparatus including an external sheath 5302 that isinverted and compressed (but without an installing handle in thisexample), a tip 5327, a proximal base 5335, and a pair of inner sheaths5315, 5317. The endoscope sheath apparatus is shown coiled andpositioned within a packaging (e.g., box 5366).

As mentioned above, the installing handles described herein may also beuseful for removing the endoscope sheath apparatus form theendoscope(s). For example, FIGS. 54A-54C illustrate removal of theapparatus from the endoscope assemblies shown in FIGS. 51A-51D. Theinstalling handle 5081 may first be disengaged from the endoscopeproximal end region 5287, and then driven 5490 (by pushing, pulling,etc.) distally as shown in FIG. 54B. as the installing handle movesdistally, the external sheath is pulled over itself and inverts so thatany contamination is held between the folded-over (inverted) portions ofthe external sheath 5002″ so that only the inner (uncontaminated)portion is exposed proximally. The distal funnel-shape 5088 on theinstalling handle may help collect any contaminant material and invertthe external sheath 5002.

As mentioned above, the inner sheaths 5015, 5017 may be sealed at theirproximal end (e.g., by crimping, heating, etc.) preventing contaminationbefore the cap is disengaged and they are withdrawn distally, as shownin FIG. 54C. Thereafter, the endoscope sheath assembly may be disposedof. Prior to removing the endoscope sheath assembly the assembly may bepressurized to confirm that no leaks have developed that may otherwiseindicate contamination of the endoscope(s) was likely to have occurred.

Method of Making

Also described herein are methods of making any of these apparatuses.For example, a method of making an endoscope sheath device that isconfigured to prevent contamination of an endoscope is schematicallyillustrated in FIG. 55 . In general these methods may include sealing adistal end region of a tubular internal sheath to an opening through acap that is configured to couple to a distal end region of the endoscope5503. Sealing may be performed by any appropriate technique, includingadhesive bonding, laser bonding (welding), etc. The tubular innersheath(s) may be sealed by inserted into a hole through the cap andsecured with the outer surface of the internal sheath bonded to theinner diameter of the hole. The tubular internal sheath may beconfigured to be inserted through a lumen of the endoscope. Thereafterthe distal end region of a tubular external sheath may be sealed to thecap, including sealing around an outer perimeter of the cap 5505. Thetubular external sheath may be configured to fit over an outer surfaceof the endoscope. The tubular external sheath may be sealed to the capby an adhesive and/or a weld, or the like. In some example a gasket orring (e.g. elastomeric material) may be used to seal and secure thetubular external sheath to the cap.

In some cases the parts may be formed and/or assembled first. Forexample, as shown in FIG. 55 , an optional step may include coating thedevice, e.g., the inner sheath(s) and/or the cap and/or the externalsheath with a material, such as a hydrophilic coating. In particular theinternal tubular members may be coated with a hydrophilic coating byfirst coating a flat layer (e.g., sheet) of material, then forming thetubular inner sheath 5501. In some examples the cap may be formed aswell. Optionally in some examples the internal sheath may be reinforcedalong a portion (e.g. distal end) or all of it length to preventedcollapse when bending.

Optionally, the assembly including the cap, tubular external sheath andtubular internal sheath(s) may be primed or prepared by loading into aninstalling handle, as described above 5557. For example, the tubularexternal sheath may be compressed (e.g., scrunched, folded, etc.) into achamber of the installing handle with the internal sheath(s) extendingproximally from the cap through the installing handle and the externalsheath. The assembly (with or without the installing handle) may besterilized. Finally, the endoscope sheath apparatus assembly may bepackaged 5559. In some example the endoscope sheath apparatus may bepackaged in a compact, coiled configuration.

A person of ordinary skill in the art will recognize that any process ormethod disclosed herein can be modified in many ways. The processparameters and sequence of the steps described and/or illustrated hereinare given by way of example only and can be varied as desired. Forexample, while the steps illustrated and/or described herein may beshown or discussed in a particular order, these steps do not necessarilyneed to be performed in the order illustrated or discussed.

The various exemplary methods described and/or illustrated herein mayalso omit one or more of the steps described or illustrated herein orcomprise additional steps in addition to those disclosed. Further, astep of any method as disclosed herein can be combined with any one ormore steps of any other method as disclosed herein.

The processor as described herein can be configured to perform one ormore steps of any method disclosed herein. Alternatively or incombination, the processor can be configured to combine one or moresteps of one or more methods as disclosed herein.

When a feature or element is herein referred to as being “on” anotherfeature or element, it can be directly on the other feature or elementor intervening features and/or elements may also be present. Incontrast, when a feature or element is referred to as being “directlyon” another feature or element, there are no intervening features orelements present. It will also be understood that, when a feature orelement is referred to as being “connected”, “attached” or “coupled” toanother feature or element, it can be directly connected, attached orcoupled to the other feature or element or intervening features orelements may be present. In contrast, when a feature or element isreferred to as being “directly connected”, “directly attached” or“directly coupled” to another feature or element, there are nointervening features or elements present. Although described or shownwith respect to one embodiment, the features and elements so describedor shown can apply to other embodiments. It will also be appreciated bythose of skill in the art that references to a structure or feature thatis disposed “adjacent” another feature may have portions that overlap orunderlie the adjacent feature.

Terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention.For example, as used herein, the singular forms “a”, “an” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise. It will be further understood that the terms“comprises” and/or “comprising,” when used in this specification,specify the presence of stated features, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, steps, operations, elements, components, and/orgroups thereof. As used herein, the term “and/or” includes any and allcombinations of one or more of the associated listed items and may beabbreviated as “/”.

Spatially relative terms, such as “under”, “below”, “lower”, “over”,“upper” and the like, may be used herein for ease of description todescribe one element or feature's relationship to another element(s) orfeature(s) as illustrated in the figures. It will be understood that thespatially relative terms are intended to encompass differentorientations of the device in use or operation in addition to theorientation depicted in the figures. For example, if a device in thefigures is inverted, elements described as “under” or “beneath” otherelements or features would then be oriented “over” the other elements orfeatures. Thus, the exemplary term “under” can encompass both anorientation of over and under. The device may be otherwise oriented(rotated 90 degrees or at other orientations) and the spatially relativedescriptors used herein interpreted accordingly. Similarly, the terms“upwardly”, “downwardly”, “vertical”, “horizontal” and the like are usedherein for the purpose of explanation only unless specifically indicatedotherwise.

Although the terms “first” and “second” may be used herein to describevarious features/elements (including steps), these features/elementsshould not be limited by these terms, unless the context indicatesotherwise. These terms may be used to distinguish one feature/elementfrom another feature/element. Thus, a first feature/element discussedbelow could be termed a second feature/element, and similarly, a secondfeature/element discussed below could be termed a first feature/elementwithout departing from the teachings of the present invention.

Throughout this specification and the claims which follow, unless thecontext requires otherwise, the word “comprise”, and variations such as“comprises” and “comprising” means various components can be co-jointlyemployed in the methods and articles (e.g., compositions and apparatusesincluding device and methods). For example, the term “comprising” willbe understood to imply the inclusion of any stated elements or steps butnot the exclusion of any other elements or steps.

In general, any of the apparatuses and methods described herein shouldbe understood to be inclusive, but all or a sub-set of the componentsand/or steps may alternatively be exclusive, and may be expressed as“consisting of” or alternatively “consisting essentially of” the variouscomponents, steps, sub-components or sub-steps.

As used herein in the specification and claims, including as used in theexamples and unless otherwise expressly specified, all numbers may beread as if prefaced by the word “about” or “approximately,” even if theterm does not expressly appear. The phrase “about” or “approximately”may be used when describing magnitude and/or position to indicate thatthe value and/or position described is within a reasonable expectedrange of values and/or positions. For example, a numeric value may havea value that is +/−0.1% of the stated value (or range of values), +/−1%of the stated value (or range of values), +/−2% of the stated value (orrange of values), +/−5% of the stated value (or range of values), +/−10%of the stated value (or range of values), etc. Any numerical valuesgiven herein should also be understood to include about or approximatelythat value, unless the context indicates otherwise. For example, if thevalue “10” is disclosed, then “about 10” is also disclosed. Anynumerical range recited herein is intended to include all sub-rangessubsumed therein. It is also understood that when a value is disclosedthat “less than or equal to” the value, “greater than or equal to thevalue” and possible ranges between values are also disclosed, asappropriately understood by the skilled artisan. For example, if thevalue “X” is disclosed the “less than or equal to X” as well as “greaterthan or equal to X” (e.g., where X is a numerical value) is alsodisclosed. It is also understood that the throughout the application,data is provided in a number of different formats, and that this data,represents endpoints and starting points, and ranges for any combinationof the data points. For example, if a particular data point “10” and aparticular data point “15” are disclosed, it is understood that greaterthan, greater than or equal to, less than, less than or equal to, andequal to 10 and 15 are considered disclosed as well as between 10 and15. It is also understood that each unit between two particular unitsare also disclosed. For example, if 10 and 15 are disclosed, then 11,12, 13, and 14 are also disclosed.

Although various illustrative embodiments are described above, any of anumber of changes may be made to various embodiments without departingfrom the scope of the invention as described by the claims. For example,the order in which various described method steps are performed mayoften be changed in alternative embodiments, and in other alternativeembodiments one or more method steps may be skipped altogether. Optionalfeatures of various device and system embodiments may be included insome embodiments and not in others. Therefore, the foregoing descriptionis provided primarily for exemplary purposes and should not beinterpreted to limit the scope of the invention as it is set forth inthe claims.

The examples and illustrations included herein show, by way ofillustration and not of limitation, specific embodiments in which thesubject matter may be practiced. As mentioned, other embodiments may beutilized and derived there from, such that structural and logicalsubstitutions and changes may be made without departing from the scopeof this disclosure. Such embodiments of the inventive subject matter maybe referred to herein individually or collectively by the term“invention” merely for convenience and without intending to voluntarilylimit the scope of this application to any single invention or inventiveconcept, if more than one is, in fact, disclosed. Thus, althoughspecific embodiments have been illustrated and described herein, anyarrangement calculated to achieve the same purpose may be substitutedfor the specific embodiments shown. This disclosure is intended to coverany and all adaptations or variations of various embodiments.Combinations of the above embodiments, and other embodiments notspecifically described herein, will be apparent to those of skill in theart upon reviewing the above description.

What is claimed is:
 1. An endoscope sheath device configured to preventcontamination of an endoscope, the device comprising: an externalsheath; a cap sealingly coupled to a distal end of the external sheath;and one or more internal sheaths each extending within the externalsheath, wherein each internal sheath has one or more internal lumens andis configured to pass through a lumen of the endoscope to form afluid-impermeable internal contamination barrier, further wherein eachinternal sheath is sealingly coupled to the cap so that the one or moreinternal lumens is open through the cap.
 2. The device in claim 1,wherein the external sheath is a dynamically rigidizing structure. 3.The device of claim 1, wherein the external sheath is shorter than theone or more internal sheaths.
 4. The device of claim 1, wherein the capis at least partially transparent.
 5. The device of claim 1, wherein thecap comprises a transparent region configured to align with a camera ofthe endoscope.
 6. The device of claim 1, wherein the cap is configuredto secure to the distal end of the endoscope.
 7. The device of claim 1,wherein the cap is configured to secure to the distal end of theendoscope and comprises one or more of: a friction fitting configured tosecure the cap to the distal end of the endoscope, a snap fit configuredto secure the cap to the distal end of the endoscope, a magnetconfigured to secure the cap to the distal end of the endoscope, abayonet connector configured to secure the cap to the distal end of theendoscope, or a threaded region configured to secure the cap to thedistal end of the endoscope.
 8. The device of claim 1, wherein at leastone of the one or more internal sheaths comprises a multi-lumencatheter.
 9. The device of claim 1, wherein at least one of the one ormore internal sheaths comprises a working channel liner having a workingchannel lumen.
 10. The device of claim 1, further comprising a proximalattachment on the external sheath configured to seal the external sheathto an outer surface of the endoscope.
 11. The device of claim 10,wherein the proximal attachment comprises an elastic attachment.
 12. Thedevice of claim 1, wherein the external sheath is flexible and isconfigured to form an external fluid-impermeable contamination barrier.13. The device of claim 1, wherein the cap comprises a substantiallycylindrical mating surface configured to mate with a distal end of theendoscope when compressed from an oval resting cross-sectionalconfiguration into a substantially circular mating cross-sectionalconfiguration.
 14. The device of claim 1, wherein the one or moreinternal sheaths comprises a working channel liner configured to form aninternal fluid-impermeable contamination barrier within a workingchannel of the endoscope.
 15. The device of claim 1, further comprisinga crimping region at a proximal end region of the internal sheath thatis configured to be crimped to seal the one or more internal lumensafter use to prevent contamination during removal of the one or moreinternal sheaths from within a lumen of the endoscope.
 16. The device ofclaim 15, wherein the crimping region is configured to be heat sealedand/or pressure sealed.
 17. The device of claim 1, wherein an internallumen of the one or more internal sheaths comprises a hydrophiliccoating.
 18. An endoscope sheath device configured to preventcontamination of an endoscope, the device comprising: an external sheathconfigured to extend over the endoscope to form a fluid-impermeableexternal contamination barrier; a cap sealingly coupled to a distal endof the external sheath, wherein the cap is configured to mate with adistal end of the endoscope; and one or more internal sheaths eachhaving one or more internal lumens, each of the one or more internalsheaths extending within the external sheath, wherein each of the one ormore internal sheaths are configured to pass through a lumen of theendoscope to form a fluid-impermeable internal contamination barrier,wherein each of the one or more internal sheaths is sealingly coupled tothe cap so that the one or more internal lumens are open through thecap.
 19. An endoscope sheath device configured to prevent contaminationof an endoscope, the device comprising: an external sheath configured tofit over the endoscope; a cap sealingly coupled to a distal end of theexternal sheath; one or more internal sheaths each extending within theexternal sheath and configured to fit within a lumen extending throughthe endoscope, wherein each internal sheath has one or more internallumens, further wherein each internal sheath is sealingly coupled to thecap so that the one or more internal lumens is open through the cap; anda sealing region at a proximal end of the one or more internal sheathsthat is configured to be sealed after use to prevent contaminationduring removal of the one or more internal sheaths from within the lumenextending through the endoscope.
 20. The device of claim 19, wherein thesealing region comprises a crimping region.
 21. The device of claim 19,wherein the sealing region is configured to be heat sealed.
 22. Thedevice of claim 19, wherein the sealing region is configured to bepressure sealed.
 23. The device in claim 19, wherein the external sheathis a dynamically rigidizing structure.
 24. The device of claim 19,wherein the external sheath is shorter than the one or more internalsheaths.
 25. The device of claim 19, wherein the cap is at leastpartially transparent.
 26. The device of claim 19, wherein the capcomprises a transparent region configured to align with a camera of theendoscope.
 27. The device of claim 19, wherein the cap is configured tosecure to the distal end of the endoscope.
 28. The device of claim 19,wherein the cap is configured to secure to the distal end of theendoscope and comprises s of: a friction fitting configured to securethe cap to the distal end of the endoscope, a snap fit configured tosecure the cap to the distal end of the endoscope, a magnet configuredto secure the cap to the distal end of the endoscope, a bayonetconnector configured to secure the cap to the distal end of theendoscope, or a threaded region configured to secure the cap to thedistal end of the endoscope.
 29. The device of claim 19, wherein the capcomprises a cylindrical mating surface configured to mate with a distalend of the endoscope when compressed from an oval restingcross-sectional configuration into a circular mating cross-sectionalconfiguration.
 30. An endoscope sheath device configured to preventcontamination of an endoscope, the device comprising: a flexibleexternal sheath; a cap sealingly coupled to a distal end of the externalsheath; and an internal sheath comprising a multi-lumen catheterextending within the external sheath, wherein the internal sheath issealingly coupled to the cap so that the lumens of the multi-lumencatheter are open through the cap, further wherein the internal sheathis configured to extend through a lumen of the endoscope; and a crimpingregion at a proximal end region of the internal sheath that isconfigured to be crimped to seal the lumens of the multi-lumen catheterafter use to prevent contamination during removal of the internal sheathfrom within the lumen of the endoscope.